Shivering Caused by Spinal AnesthesiaPhase 2NCT02382432
Dexmedetomidine in Post Spinal Anesthesia Shivering
A Phase 2 study testing Pethidine 0.4mg/kg and Dexmedetomidine in people with Shivering Caused by Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shivering Caused by Spinal Anesthesia
- What is being tested?
- Pethidine 0.4mg/kg and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2013to Dec 2014
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period
Who cannot join
- Patients with BMI>30 kg /m2
- Initial body temperature >38 C or <36 C and those with a history of convulsions
- Multiple allergies
- Thyroid disease
- Parkinson's disease
- Dysautonomia
Show all 13Show fewer
- Raynaud's syndrome
- Hypertension
- Coronary artery disease or other cardio-respiratory or neuromuscular pathology
- Middle ear pathology
- A known history of alcohol use
- Treatment with sedative hypnotic agents or vasodilators
- Having contraindications to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university hospital, Assiut, Egypt
Asyut, Assiut Governorate, 715715
About this study
Official title: Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.
This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.
Read the detailed description
Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.
- Conditions
- Shivering Caused by Spinal Anesthesia
- Being tested
- Pethidine 0.4mg/kg, Dexmedetomidine
- Keywords
- Anesthesia, dexmedetomidine, pethidine, shivering, spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pethidine 0.4mg/kgDrug
Also called Meperidine
2ml intravenous bolus slowly injected in 2minutes.
DexmedetomidineDrug
Also called Precedex
2ml intravenous bolus slowly injected in 2minutes
| Study group | Role | What they receive |
|---|---|---|
| Pethidine 0.4mg/kg iv | Active comparator | interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished. Receives: Drug: Pethidine 0.4mg/kg |
| DEX. I | Active comparator | Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished. Receives: Drug: Dexmedetomidine |
| DEX. II | Active comparator | Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. Receives: Drug: Dexmedetomidine |
| DEX III | Active comparator | Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering response rate (%)
complete cessation of shivering activity within 10 minutes after study drug injection
Measured: 10 minutes
Secondary outcomes (5)
Systolic blood pressure
find for systolic hypotension, hypertension
Measured: 6 hours after study drug injection
sedation
using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking).
Measured: 6 hours after study drug injection
peripheral arterial saturation
find for hypoxia
Measured: 6 hours after study drug injection
diastolic blood pressure
find for diastolic hypertension or hypotension
Measured: 6 hours after study drug injection
Postoperative adverse events
postoperative nausea and vomiting, urine retention, post dural puncture headache ect.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shivering Caused by Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382432
- Sponsor's protocol ID
- IRB00008718
- Status last verified
- Mar 2015
- First submitted
- 25 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
PubMed 27228512
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.
- ClinicalTrials.gov ID
- NCT02382432
- Acronym / sponsor ID
- IRB00008718
- Conditions
- Shivering Caused by Spinal Anesthesia
- Keywords
- Anesthesia, dexmedetomidine, pethidine, shivering, spinal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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.
This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.
Detailed description
Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pethidine 0.4mg/kg iv | Active comparator | Drug: Pethidine 0.4mg/kginterventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished. |
| DEX. I | Active comparator | Drug: DexmedetomidineInterventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished. |
| DEX. II | Active comparator | Drug: DexmedetomidineInterventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. |
| DEX III | Active comparator | Drug: DexmedetomidineInterventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period
Key exclusion criteria (13 listed)
- Patients with BMI>30 kg /m2
- Initial body temperature >38 C or <36 C and those with a history of convulsions
- Multiple allergies
- Thyroid disease
- Parkinson's disease
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 |
|---|---|---|
| Pethidine 0.4mg/kgAlso: Meperidine2ml intravenous bolus slowly injected in 2minutes. | Drug | Pethidine 0.4mg/kg iv |
| DexmedetomidineAlso: Precedex2ml intravenous bolus slowly injected in 2minutes | Drug | DEX III, DEX. I, DEX. II |
Primary outcome
Shivering response rate (%)
Time frame: 10 minutes
complete cessation of shivering activity within 10 minutes after study drug injection
5 secondary outcomes
Systolic blood pressure
Time frame: 6 hours after study drug injection
sedation
Time frame: 6 hours after study drug injection
peripheral arterial saturation
Time frame: 6 hours after study drug injection
diastolic blood pressure
Time frame: 6 hours after study drug injection
Postoperative adverse events
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 27228512Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
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.
Hala S Abdel-Ghaffar, MD principal investigator
assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pethidine 0.4mg/kg and Dexmedetomidine in people with Shivering Caused by Spinal Anesthesia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 13 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: finished, as of the sponsor's last update on 6 Mar 2015. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering response rate (%) (time frame: 10 minutes). 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 NCT02382432, which also lists 1 linked publication.
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 6 Mar 2015.