Spinal AnesthesiaNCT05063292
Effect of Prewarming On Skin Temperature Changes
A study testing Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation in people with Spinal Anesthesia and Hypothermia Following Anesthesia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming
- What is being tested?
- Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2021to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III
- 50-80 years old
- Patients scheduled for transurethral baldder resection
Who cannot join
- Female gender
- Uncoordinated patients
- Have coagulopathy,
- Known allergies to drugs to be used,
- Patients diagnosed with severe hypovolemia
- Skin infection at the injection site.
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- Body mass index greater than 35m2/kg
- patients with severe endocrinological disease
- Patients with cardiovascular diseases
- patients with severe aortic stenosis or severe mitral stenosis
- patients with increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bozyaka Training and Research Hospital
Izmir, Karabağlar, 35170
About this study
Official title: Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.
Read the detailed description
In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded.
- Conditions
- Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming, Core Temperature, Urological Cancer
- Being tested
- Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation
- Keywords
- hypothermia, peripheral temperature, spinal anesthesia, forced-air warming
- Medical subject headings
- Urologic Neoplasms, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operationProcedure or surgery
Core temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients covered with a 41 centigrade degrees double layered cotton cloth |
| Prewarmed group | Experimental | Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation Receives: Procedure: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral skin temperature at ( F0)
F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: just after spinal anesthesia done
peripheral skin temperature at( S0)
S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: just after spinal anesthesia done
peripheral skin temperature( T0)
T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: just after spinal anesthesia done
peripheral skin temperature( M0)
M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: just after spinal anesthesia done
peripheral skin temperature( F1)
F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 60 seconds after spinal anesthesia done
peripheral skin temperature( F2)
F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 120 seconds after spinal anesthesia done
peripheral skin temperature( F3)
F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 180 seconds after spinal anesthesia done
peripheral skin temperature( F4)
F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 4 minute after spinal anesthesia done
peripheral skin temperature( F5)
F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 5 minute after spinal anesthesia done
peripheral skin temperature( F6)
F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 6 minute after spinal anesthesia done
peripheral skin temperature( F7)
F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 7 minute after spinal anesthesia done
peripheral skin temperature( F8)
F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 8 minute after spinal anesthesia done
peripheral skin temperature( F9)
F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 9 minute after spinal anesthesia done
peripheral skin temperature( F10)
F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 10 minute after spinal anesthesia done
peripheral skin temperature( F15)
F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 15 minute after spinal anesthesia done
peripheral skin temperature( F20)
F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 20 minute after spinal anesthesia done
peripheral skin temperature( F25)
F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 25 minute after spinal anesthesia done
peripheral skin temperature( F30)
F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 30 minute after spinal anesthesia done
peripheral skin temperature( F35)
F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 35 minute after spinal anesthesia done
peripheral skin temperature( F40)
F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 40 minute after spinal anesthesia done
peripheral skin temperature( F45)
F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 45 minute after spinal anesthesia done
peripheral skin temperature( F50)
F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 50 minute after spinal anesthesia done
peripheral skin temperature( F55)
F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 55 minute after spinal anesthesia done
peripheral skin temperature( F60)
F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
Measured: 60 minute after spinal anesthesia done
peripheral skin temperature at( S1)
S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 60 seconds after spinal anesthesia done
peripheral skin temperature at( S2)
S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 120 seconds after spinal anesthesia done
peripheral skin temperature at( S3)
S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 180 seconds after spinal anesthesia done
peripheral skin temperature at( S4)
S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 4 minute after spinal anesthesia done
peripheral skin temperature at( S5)
S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 5 minute after spinal anesthesia done
peripheral skin temperature at( S6)
S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 6 minute after spinal anesthesia done
peripheral skin temperature at( S7)
S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 7 minute after spinal anesthesia done
peripheral skin temperature at( S8)
S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 8 minute after spinal anesthesia done
peripheral skin temperature at( S9)
S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 9 minute after spinal anesthesia done
peripheral skin temperature at( S10)
S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 10 minute after spinal anesthesia done
peripheral skin temperature at( S15)
S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 15 minute after spinal anesthesia done
peripheral skin temperature at( S20)
S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 20 minute after spinal anesthesia done
peripheral skin temperature at( S25)
S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 25 minute after spinal anesthesia done
peripheral skin temperature at( S30)
S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 30 minute after spinal anesthesia done
peripheral skin temperature at( S35)
S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 35 minute after spinal anesthesia done
peripheral skin temperature at( S40)
S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 40 minute after spinal anesthesia done
peripheral skin temperature at( S45)
S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 45 minute after spinal anesthesia done
peripheral skin temperature at( S50)
S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 50 minute after spinal anesthesia done
peripheral skin temperature at( S55)
S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 55 minute after spinal anesthesia done
peripheral skin temperature at( S60)
S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
Measured: 60 minute after spinal anesthesia done
peripheral skin temperature( T1)
T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 60 seconds after spinal anesthesia done
peripheral skin temperature( T2)
T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 120 seconds after spinal anesthesia done
peripheral skin temperature( T3)
T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 180 seconds after spinal anesthesia done
peripheral skin temperature( T4)
T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 4 minute after spinal anesthesia done
peripheral skin temperature( T5)
T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 5 minute after spinal anesthesia done
peripheral skin temperature( T6)
T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 6 minute after spinal anesthesia done
peripheral skin temperature( T7)
T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe
Measured: 7 minute after spinal anesthesia done
peripheral skin temperature( T8)
T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 8 minute after spinal anesthesia done
peripheral skin temperature( T9)
T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 9 minute after spinal anesthesia done
peripheral skin temperature( T10)
T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 10 minute after spinal anesthesia done
peripheral skin temperature( T15)
T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 15 minute after spinal anesthesia done
peripheral skin temperature( T20)
T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 20 minute after spinal anesthesia done
peripheral skin temperature( T25)
T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe
Measured: 25 minute after spinal anesthesia done
peripheral skin temperature( T30)
T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 30 minute after spinal anesthesia done
peripheral skin temperature( T35)
T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 35 minute after spinal anesthesia done
peripheral skin temperature( T40)
T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 40 minute after spinal anesthesia done
peripheral skin temperature( T45)
T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 45 minute after spinal anesthesia done
peripheral skin temperature( T50)
T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 50 minute after spinal anesthesia done
peripheral skin temperature( T55)
T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 55 minute after spinal anesthesia done
peripheral skin temperature( T60)
T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
Measured: 60 minute after spinal anesthesia done
peripheral skin temperature( M1)
M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 60 seconds after spinal anesthesia done
peripheral skin temperature( M2)
M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 120 seconds after spinal anesthesia done
peripheral skin temperature( M3)
M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 180 seconds after spinal anesthesia done
peripheral skin temperature( M4)
M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 4 minute after spinal anesthesia done
peripheral skin temperature( M5)
M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 5 minute after spinal anesthesia done
peripheral skin temperature( M6)
M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 6 minute after spinal anesthesia done
peripheral skin temperature( M7)
M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 7 minute after spinal anesthesia done
peripheral skin temperature( M8)
M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 8 minute after spinal anesthesia done
peripheral skin temperature( M9)
M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 9 minute after spinal anesthesia done
peripheral skin temperature( M10)
M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 10 minute after spinal anesthesia done
peripheral skin temperature( M15)
M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 15 minute after spinal anesthesia done
peripheral skin temperature( M20)
M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 20 minute after spinal anesthesia done
peripheral skin temperature( M25)
M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 25 minute after spinal anesthesia done
peripheral skin temperature( M30)
M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 30 minute after spinal anesthesia done
peripheral skin temperature( M35)
M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 35 minute after spinal anesthesia done
peripheral skin temperature( M40)
M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 40 minute after spinal anesthesia done
peripheral skin temperature( M45)
M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 45 minute after spinal anesthesia done
peripheral skin temperature( M50)
M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 50 minute after spinal anesthesia done
peripheral skin temperature( M55)
M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 55 minute after spinal anesthesia done
peripheral skin temperature( M60)
M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
Measured: 60 minute after spinal anesthesia done
Secondary outcomes (15)
core tympanic membrane temperature (C0)
centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Measured: just before spinal anesthesia done
core tympanic membrane temperature(C1)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Measured: 15 minute after spinal anesthesia done
core tympanic membrane temperature(C2)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Measured: 30 minute after spinal anesthesia done
core tympanic membrane temperature(C3)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Measured: 45 minute after spinal anesthesia done
core tympanic membrane temperature(C4)
centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,
Measured: 60 minute after spinal anesthesia done
thermal comfort scale
thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat
Measured: Immediately after the surgery
shivering score(h0)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: just before spinal anesthesia done
shivering score(h1)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 15 minute after spinal anesthesia done
shivering score(h2)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 30 minute after spinal anesthesia done
shivering score(h3)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 45 minute after spinal anesthesia done
shivering score(h4)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 60 minute after spinal anesthesia done
shivering score(h5)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 75 minute after spinal anesthesia done
shivering score(h6)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 90 minute after spinal anesthesia done
shivering score(h7)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 105 minute after spinal anesthesia done
shivering score(h8)
0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body
Measured: 120 minute after spinal anesthesia done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start5 Oct 2021 (estimated)
- Primary completion10 Nov 2021 (estimated)
- Study completion18 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study covers 2 groups. Group I will be covered with warmed double layered cotton cloth. Group II will be covered with air forced blanket.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NEGIN NAYEBI, Bozyaka Training and Research Hospital
- Investigators
- Halide Hande Şahinkaya, Specialist, Study chair, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063292
- Sponsor's protocol ID
- NeginIzmirBozyaka
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.
PubMed 29938773Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.
PubMed 30579334Fradkin AJ, Zazryn TR, Smoliga JM. Effects of warming-up on physical performance: a systematic review with meta-analysis. J Strength Cond Res. 2010 Jan;24(1):140-8. doi: 10.1519/JSC.0b013e3181c643a0.
PubMed 19996770Frank SM, El-Rahmany HK, Tran KM, Vu B, Raja SN. Comparison of lower extremity cutaneous temperature changes in patients receiving lumbar sympathetic ganglion blocks versus epidural anesthesia. J Clin Anesth. 2000 Nov;12(7):525-30. doi: 10.1016/s0952-8180(00)00207-5.
PubMed 11137413Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.
PubMed 26571323Nayebi N, Tekgul ZT, Sahinkaya HH. Effect of Prewarming on Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of the Bladder. J Perianesth Nurs. 2024 Jun;39(3):391-396. doi: 10.1016/j.jopan.2023.08.020. Epub 2024 Jan 11.
PubMed 38206216
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
- ClinicalTrials.gov ID
- NCT05063292
- Acronym / sponsor ID
- NeginIzmirBozyaka
- Conditions
- Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming, Core Temperature, Urological Cancer
- Keywords
- hypothermia, peripheral temperature, spinal anesthesia, forced-air warming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Oct 2021 (estimated)
- Primary completion
- 10 Nov 2021 (estimated)
- Study completion
- 18 Nov 2021 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.
Detailed description
In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study covers 2 groups. Group I will be covered with warmed double layered cotton cloth. Group II will be covered with air forced blanket.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients covered with a 41 centigrade degrees double layered cotton cloth |
| Prewarmed group | Experimental | Procedure: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operationPatients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II-III
- 50-80 years old
- Patients scheduled for transurethral baldder resection
Key exclusion criteria (11 listed)
- Female gender
- Uncoordinated patients
- Have coagulopathy,
- Known allergies to drugs to be used,
- Patients diagnosed with severe hypovolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operationCore temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. | Procedure or surgery | Prewarmed group |
Primary outcome
peripheral skin temperature at ( F0)
Time frame: just after spinal anesthesia done
F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S0)
Time frame: just after spinal anesthesia done
S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T0)
Time frame: just after spinal anesthesia done
T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M0)
Time frame: just after spinal anesthesia done
M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( F1)
Time frame: 60 seconds after spinal anesthesia done
F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F2)
Time frame: 120 seconds after spinal anesthesia done
F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F3)
Time frame: 180 seconds after spinal anesthesia done
F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F4)
Time frame: 4 minute after spinal anesthesia done
F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F5)
Time frame: 5 minute after spinal anesthesia done
F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F6)
Time frame: 6 minute after spinal anesthesia done
F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F7)
Time frame: 7 minute after spinal anesthesia done
F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F8)
Time frame: 8 minute after spinal anesthesia done
F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F9)
Time frame: 9 minute after spinal anesthesia done
F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F10)
Time frame: 10 minute after spinal anesthesia done
F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F15)
Time frame: 15 minute after spinal anesthesia done
F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F20)
Time frame: 20 minute after spinal anesthesia done
F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F25)
Time frame: 25 minute after spinal anesthesia done
F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F30)
Time frame: 30 minute after spinal anesthesia done
F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F35)
Time frame: 35 minute after spinal anesthesia done
F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F40)
Time frame: 40 minute after spinal anesthesia done
F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F45)
Time frame: 45 minute after spinal anesthesia done
F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F50)
Time frame: 50 minute after spinal anesthesia done
F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F55)
Time frame: 55 minute after spinal anesthesia done
F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F60)
Time frame: 60 minute after spinal anesthesia done
F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S1)
Time frame: 60 seconds after spinal anesthesia done
S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S2)
Time frame: 120 seconds after spinal anesthesia done
S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S3)
Time frame: 180 seconds after spinal anesthesia done
S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S4)
Time frame: 4 minute after spinal anesthesia done
S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S5)
Time frame: 5 minute after spinal anesthesia done
S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S6)
Time frame: 6 minute after spinal anesthesia done
S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S7)
Time frame: 7 minute after spinal anesthesia done
S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S8)
Time frame: 8 minute after spinal anesthesia done
S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S9)
Time frame: 9 minute after spinal anesthesia done
S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S10)
Time frame: 10 minute after spinal anesthesia done
S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S15)
Time frame: 15 minute after spinal anesthesia done
S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S20)
Time frame: 20 minute after spinal anesthesia done
S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S25)
Time frame: 25 minute after spinal anesthesia done
S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S30)
Time frame: 30 minute after spinal anesthesia done
S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S35)
Time frame: 35 minute after spinal anesthesia done
S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S40)
Time frame: 40 minute after spinal anesthesia done
S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S45)
Time frame: 45 minute after spinal anesthesia done
S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S50)
Time frame: 50 minute after spinal anesthesia done
S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S55)
Time frame: 55 minute after spinal anesthesia done
S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S60)
Time frame: 60 minute after spinal anesthesia done
S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T1)
Time frame: 60 seconds after spinal anesthesia done
T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T2)
Time frame: 120 seconds after spinal anesthesia done
T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T3)
Time frame: 180 seconds after spinal anesthesia done
T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T4)
Time frame: 4 minute after spinal anesthesia done
T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T5)
Time frame: 5 minute after spinal anesthesia done
T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T6)
Time frame: 6 minute after spinal anesthesia done
T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T7)
Time frame: 7 minute after spinal anesthesia done
T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T8)
Time frame: 8 minute after spinal anesthesia done
T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T9)
Time frame: 9 minute after spinal anesthesia done
T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T10)
Time frame: 10 minute after spinal anesthesia done
T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T15)
Time frame: 15 minute after spinal anesthesia done
T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T20)
Time frame: 20 minute after spinal anesthesia done
T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T25)
Time frame: 25 minute after spinal anesthesia done
T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe
peripheral skin temperature( T30)
Time frame: 30 minute after spinal anesthesia done
T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T35)
Time frame: 35 minute after spinal anesthesia done
T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T40)
Time frame: 40 minute after spinal anesthesia done
T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T45)
Time frame: 45 minute after spinal anesthesia done
T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T50)
Time frame: 50 minute after spinal anesthesia done
T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T55)
Time frame: 55 minute after spinal anesthesia done
T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T60)
Time frame: 60 minute after spinal anesthesia done
T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M1)
Time frame: 60 seconds after spinal anesthesia done
M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M2)
Time frame: 120 seconds after spinal anesthesia done
M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M3)
Time frame: 180 seconds after spinal anesthesia done
M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M4)
Time frame: 4 minute after spinal anesthesia done
M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M5)
Time frame: 5 minute after spinal anesthesia done
M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M6)
Time frame: 6 minute after spinal anesthesia done
M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M7)
Time frame: 7 minute after spinal anesthesia done
M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M8)
Time frame: 8 minute after spinal anesthesia done
M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M9)
Time frame: 9 minute after spinal anesthesia done
M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M10)
Time frame: 10 minute after spinal anesthesia done
M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M15)
Time frame: 15 minute after spinal anesthesia done
M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M20)
Time frame: 20 minute after spinal anesthesia done
M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M25)
Time frame: 25 minute after spinal anesthesia done
M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M30)
Time frame: 30 minute after spinal anesthesia done
M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M35)
Time frame: 35 minute after spinal anesthesia done
M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M40)
Time frame: 40 minute after spinal anesthesia done
M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M45)
Time frame: 45 minute after spinal anesthesia done
M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M50)
Time frame: 50 minute after spinal anesthesia done
M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M55)
Time frame: 55 minute after spinal anesthesia done
M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M60)
Time frame: 60 minute after spinal anesthesia done
M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
15 secondary outcomes
core tympanic membrane temperature (C0)
Time frame: just before spinal anesthesia done
core tympanic membrane temperature(C1)
Time frame: 15 minute after spinal anesthesia done
core tympanic membrane temperature(C2)
Time frame: 30 minute after spinal anesthesia done
core tympanic membrane temperature(C3)
Time frame: 45 minute after spinal anesthesia done
core tympanic membrane temperature(C4)
Time frame: 60 minute after spinal anesthesia done
thermal comfort scale
Time frame: Immediately after the surgery
shivering score(h0)
Time frame: just before spinal anesthesia done
shivering score(h1)
Time frame: 15 minute after spinal anesthesia done
shivering score(h2)
Time frame: 30 minute after spinal anesthesia done
shivering score(h3)
Time frame: 45 minute after spinal anesthesia done
shivering score(h4)
Time frame: 60 minute after spinal anesthesia done
shivering score(h5)
Time frame: 75 minute after spinal anesthesia done
shivering score(h6)
Time frame: 90 minute after spinal anesthesia done
shivering score(h7)
Time frame: 105 minute after spinal anesthesia done
shivering score(h8)
Time frame: 120 minute after spinal anesthesia done
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 29938773Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.
- Background: PubMed 30579334Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.
- Background: PubMed 19996770Fradkin AJ, Zazryn TR, Smoliga JM. Effects of warming-up on physical performance: a systematic review with meta-analysis. J Strength Cond Res. 2010 Jan;24(1):140-8. doi: 10.1519/JSC.0b013e3181c643a0.
- Background: PubMed 11137413Frank SM, El-Rahmany HK, Tran KM, Vu B, Raja SN. Comparison of lower extremity cutaneous temperature changes in patients receiving lumbar sympathetic ganglion blocks versus epidural anesthesia. J Clin Anesth. 2000 Nov;12(7):525-30. doi: 10.1016/s0952-8180(00)00207-5.
- Background: PubMed 26571323Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.
- Derived from this study: PubMed 38206216Nayebi N, Tekgul ZT, Sahinkaya HH. Effect of Prewarming on Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of the Bladder. J Perianesth Nurs. 2024 Jun;39(3):391-396. doi: 10.1016/j.jopan.2023.08.020. Epub 2024 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halide Hande Şahinkaya, Specialist study chair
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation in people with Spinal Anesthesia and Hypothermia Following Anesthesia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Negin Nayebi, MD (+905541491707, negin.naebi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral skin temperature at ( F0) (time frame: just after spinal anesthesia done). The study lists 84 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063292, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.