Cesarean Section ComplicationsPhase 3NCT03115047
Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine
A Phase 3 study testing Dexmedetomidine Injection and Meperidine Injection in people with Cesarean Section Complications, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Dexmedetomidine Injection and Meperidine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2017to 20 Aug 2020
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term > 37 weeks
- American Society of Anesthesiologists Physical Status (ASA PS) I, II
- Weight < 115 kg
- Functional epidural in situ
- In labor requiring cesarean delivery
- Class III or IV shivering on the Crossley and Mahajan standardized shivering scale between five minutes after the baby's birth to the end of the cesarean section
Who cannot join
- Refusal of the patient and/or the anesthesiologist
- Misunderstanding of the protocol
- Known allergy or contraindication to one of the study drugs
- Emergency cesarean delivery
- American Society of Anesthesiologists Physical Status III, IV, V
- Severe heart, liver or kidney disease,
Show all 10Show fewer
- Preeclampsia
- Patient taking monoamine oxydase inhibitors
- Sleep apnea
- General anesthesia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3J4
About this study
Official title: Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
Read the detailed description
It is a double blinded randomized control trial.
Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan
Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes
Control group: meperidine 0.35 mg/kg IV in 2 minutes
Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug
Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis.
The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.
- Conditions
- Cesarean Section Complications
- Being tested
- Dexmedetomidine Injection, Meperidine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine InjectionDrug
Also called precedex
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Meperidine InjectionDrug
Also called demerol
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Unique dose of dexmedetomidine injection:
* intravenous injection
* 0.35 mcg/kg
* in two minutes
* if shivering 5 minutes after delivery Receives: Drug: Dexmedetomidine Injection |
| meperidine | Active comparator | Unique dose of meperidine injection:
* intravenous injection
* 0.35 mg/kg
* in two minutes
* if shivering 5 minutes after delivery Receives: Drug: Meperidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop time
Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine)
Measured: 15 minutes
Secondary outcomes (4)
incidence of adverse effects
sedation, nausea, vomiting, hypotension and bradycardia
Measured: 24 hours
maternal satisfaction
satisfaction (yes or no) regarding experience with study drug
Measured: at 24 hours
response rate
percentage of patient responding when the drug is given
Measured: 15 minutes
cost benefice analysis
comparing cost of the drug
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start7 May 2017
- Primary completion19 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lavoie, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115047
- Sponsor's protocol ID
- 2017-7124
- Status last verified
- May 2022
- First submitted
- 8 Apr 2017
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006.
PubMed 18433676De Witte J, Sessler DI. Perioperative shivering: physiology and pharmacology. Anesthesiology. 2002 Feb;96(2):467-84. doi: 10.1097/00000542-200202000-00036. No abstract available.
PubMed 11818783Kranke P, Eberhart LH, Roewer N, Tramer MR. Pharmacological treatment of postoperative shivering: a quantitative systematic review of randomized controlled trials. Anesth Analg. 2002 Feb;94(2):453-60, table of contents. doi: 10.1097/00000539-200202000-00043.
PubMed 11812718Abdel-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 27228512Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.
PubMed 11682416Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031.
PubMed 25024466Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998 Jul-Aug;23(4):418-23. doi: 10.1016/s1098-7339(98)90017-7.
PubMed 9690596Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x.
PubMed 8147511
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine
- ClinicalTrials.gov ID
- NCT03115047
- Acronym / sponsor ID
- 2017-7124
- Conditions
- Cesarean Section Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 7 May 2017 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 14 Apr 2017 (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.
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
Detailed description
It is a double blinded randomized control trial.
Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan
Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes
Control group: meperidine 0.35 mg/kg IV in 2 minutes
Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug
Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis.
The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine InjectionUnique dose of dexmedetomidine injection: * intravenous injection * 0.35 mcg/kg * in two minutes * if shivering 5 minutes after delivery |
| meperidine | Active comparator | Drug: Meperidine InjectionUnique dose of meperidine injection: * intravenous injection * 0.35 mg/kg * in two minutes * if shivering 5 minutes after delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Term > 37 weeks
- American Society of Anesthesiologists Physical Status (ASA PS) I, II
- Weight < 115 kg
- Functional epidural in situ
- In labor requiring cesarean delivery
Key exclusion criteria (10 listed)
- Refusal of the patient and/or the anesthesiologist
- Misunderstanding of the protocol
- Known allergy or contraindication to one of the study drugs
- Emergency cesarean delivery
- American Society of Anesthesiologists Physical Status III, IV, V
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 |
|---|---|---|
| Dexmedetomidine InjectionAlso: precedex0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery | Drug | dexmedetomidine |
| Meperidine InjectionAlso: demerol0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery | Drug | meperidine |
Primary outcome
Stop time
Time frame: 15 minutes
Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine)
4 secondary outcomes
incidence of adverse effects
Time frame: 24 hours
maternal satisfaction
Time frame: at 24 hours
response rate
Time frame: 15 minutes
cost benefice analysis
Time frame: 24 hours
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 27 May 2022.
- Background: PubMed 18433676Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006.
- Background: PubMed 11818783De Witte J, Sessler DI. Perioperative shivering: physiology and pharmacology. Anesthesiology. 2002 Feb;96(2):467-84. doi: 10.1097/00000542-200202000-00036. No abstract available.
- Background: PubMed 11812718Kranke P, Eberhart LH, Roewer N, Tramer MR. Pharmacological treatment of postoperative shivering: a quantitative systematic review of randomized controlled trials. Anesth Analg. 2002 Feb;94(2):453-60, table of contents. doi: 10.1097/00000539-200202000-00043.
- Background: 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.
- Background: PubMed 11682416Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.
- Background: PubMed 25024466Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031.
- Background: PubMed 9690596Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998 Jul-Aug;23(4):418-23. doi: 10.1016/s1098-7339(98)90017-7.
- Background: PubMed 8147511Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x.
- 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.
Anne Lavoie, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine Injection and Meperidine Injection in people with Cesarean Section Complications, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 6 inclusion and 10 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 27 May 2022. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Stop time (time frame: 15 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 NCT03115047, which also lists 8 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 27 May 2022.