AnesthesiaNCT04178512
Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy
A study of Anesthesia, run by Zagazig University.
Trial summary
Spinal anesthesia is the technique of choice in transurethral prostatectomy.However,one of the common complications of spinal anesthesia is shivering which is even exaggerated in patients undergoing transurethral prostatectomy.this high incidence is most probably caused by sympathetic block and use of large amount of… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Jun 2020
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA(American society of anesthesiologists) physical status grade I-II
- BMI(body mass index) less than 35 kg/m2
- patients undergoing transurethral prostatectomy
Who cannot join
- patient refusal.
- patients with contraindications to spinal anesthesia e.g coagulopathy,anti coagulant therapy,allergy to local anesthetic,psychological disorders,...
- patient with advanced cardiopulmonary diseases or thyroid diseases.
- patients on corticosteroids therapy or on Alpha2 blocker orAlcohol.
- patients with initial body temperature above 37.5 C or below 36.5 C.
Trial locations and contacts
No sites are listed yet.
Doaa M Farid, MD contact
About this study
Official title: Effect of Intrathecal Dexamethasone Versus Fentanyl on Post Spinal Shivering in Patients Undergoing Transurethral Prostatectomy
Spinal anesthesia is the technique of choice in transurethral prostatectomy.However,one of the common complications of spinal anesthesia is shivering which is even exaggerated in patients undergoing transurethral prostatectomy.this high incidence is most probably caused by sympathetic block and use of large amount of irrigation fluid during surgery.There are two methods to reduce shivering.Previous studies showed that intrathecal fentanyl is an appropriate method to reduce shivering.Intrathecal dexamethasone could reduce shivering by regulating immune responses.
Read the detailed description
Shivering is an involuntary repetitive contractions of skeletal muscles that increases the basal metabolism and is considered to be a defense mechanism for regulating body temperature in adults .
Post spinal shivering may cause discomfort to the patient,and may aggravate wound pain by stretching incisions and increases intracranial and intra ocular pressure.Shivering may increase tissue oxygen demand as much as 500% and is accompanied by increase in minute ventilation and cardiac output to maintain aerobic metabolism.
Tympanic temperature will be recorded preoperatively,after establishment of spinal anesthesia,and every 15 minutes til the end of operation.Core temperature below 36.5 C is considered as hypothermia Shivering intensity will be assessed with a five -point scale validated by Crossly and Maharaj.
Adverse events like hypotension,bradycardia, respiratory depression,nausea and vomiting will be recorded and treated.
- Conditions
- Anesthesia
- Being tested
- Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group ControlDrug
Also called Intrathecal additives
prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives
| Study group | Role | What they receive |
|---|---|---|
| group Dexamethasone | Active comparator | Patients will receive 8 mg of dexamethasone(2ml) in addition to 2ml of hyperbaric bupivacaine 0.5% (total volume 4 ml) intrathecal injection. Receives: Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control |
| group Fentanyl | Active comparator | patients will receive 20 microgram fentanyl(diluted in sterile normal saline0.9% to 2ml)in addition to 2ml of hyperbaric bupivacaine 0.5%(total volume 4 ml) intrathecal injection. Receives: Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control |
| group Control | Active comparator | patients will receive 2ml of sterile normal saline0.9% in addition to 2ml of hyperbaric bupivacaine o.5% (total volume 4 ml) intrathecal injection. Receives: Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of shivering
compare between the effect of intrathecal dexamethasone and intrathecal fentanyl on the incidence of shivering in patients undergoing transurethral prostatectomy
Measured: intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours
Secondary outcomes (1)
comparative assessment between both drugs
compare between both drugs as regards severity of shivering,hypothermia,hemodynamic changes and side effects of the used drugs
Measured: intraoperative and in the recovery room for 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Mahmoud Ahmed, Zagazig University
- Investigators
- Abeer HM Elsawy, MD, Study chair, Faculty of medicine,Zagazig University,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178512
- Sponsor's protocol ID
- transurethral prostatectomy
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Dexamethasone Versus Fentanyl on Post Spinal Shivering in Patients Undergoing Transurethral Prostatectomy
- ClinicalTrials.gov ID
- NCT04178512
- Acronym / sponsor ID
- transurethral prostatectomy
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Dec 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Spinal anesthesia is the technique of choice in transurethral prostatectomy.However,one of the common complications of spinal anesthesia is shivering which is even exaggerated in patients undergoing transurethral prostatectomy.this high incidence is most probably caused by sympathetic block and use of large amount of irrigation fluid during surgery.There are two methods to reduce shivering.Previous studies showed that intrathecal fentanyl is an appropriate method to reduce shivering.Intrathecal dexamethasone could reduce shivering by regulating immune responses.
Detailed description
Shivering is an involuntary repetitive contractions of skeletal muscles that increases the basal metabolism and is considered to be a defense mechanism for regulating body temperature in adults .
Post spinal shivering may cause discomfort to the patient,and may aggravate wound pain by stretching incisions and increases intracranial and intra ocular pressure.Shivering may increase tissue oxygen demand as much as 500% and is accompanied by increase in minute ventilation and cardiac output to maintain aerobic metabolism.
Tympanic temperature will be recorded preoperatively,after establishment of spinal anesthesia,and every 15 minutes til the end of operation.Core temperature below 36.5 C is considered as hypothermia Shivering intensity will be assessed with a five -point scale validated by Crossly and Maharaj.
Adverse events like hypotension,bradycardia, respiratory depression,nausea and vomiting will be recorded and treated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group Dexamethasone | Active comparator | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group ControlPatients will receive 8 mg of dexamethasone(2ml) in addition to 2ml of hyperbaric bupivacaine 0.5% (total volume 4 ml) intrathecal injection. |
| group Fentanyl | Active comparator | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Controlpatients will receive 20 microgram fentanyl(diluted in sterile normal saline0.9% to 2ml)in addition to 2ml of hyperbaric bupivacaine 0.5%(total volume 4 ml) intrathecal injection. |
| group Control | Active comparator | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Controlpatients will receive 2ml of sterile normal saline0.9% in addition to 2ml of hyperbaric bupivacaine o.5% (total volume 4 ml) intrathecal injection. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA(American society of anesthesiologists) physical status grade I-II
- BMI(body mass index) less than 35 kg/m2
- patients undergoing transurethral prostatectomy
Key exclusion criteria (5 listed)
- patient refusal.
- patients with contraindications to spinal anesthesia e.g coagulopathy,anti coagulant therapy,allergy to local anesthetic,psychological disorders,...
- patient with advanced cardiopulmonary diseases or thyroid diseases.
- patients on corticosteroids therapy or on Alpha2 blocker orAlcohol.
- patients with initial body temperature above 37.5 C or below 36.5 C.
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 |
|---|---|---|
| Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group ControlAlso: Intrathecal additivesprevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives | Drug | group Control, group Dexamethasone, group Fentanyl |
Primary outcome
incidence of shivering
Time frame: intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours
compare between the effect of intrathecal dexamethasone and intrathecal fentanyl on the incidence of shivering in patients undergoing transurethral prostatectomy
1 secondary outcome
comparative assessment between both drugs
Time frame: intraoperative and in the recovery room for 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Doaa M Farid, MD contact
Abeer HM Elsawy, MD study chair
Faculty of medicine,Zagazig University,Egypt
Questions about this trial
What is this clinical trial studying?
A study of Anesthesia, run by Zagazig University.
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 5 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Fatma M Ahmed, MD (+201095790313, fatmakasem169@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of shivering (time frame: intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2019.