Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Phase 3

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: Dexmedetomidine Injection; Drug: Meperidine Injection

• Registration Number: NCT03115047
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

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 Timeline

• Study First Submitted: 2017-04-08
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-14
• Study Start: 2017-05-07
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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,
• Preeclampsia
• Patient taking monoamine oxydase inhibitors
• Sleep apnea
• General anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine Injection	Unique dose of dexmedetomidine injection: * intravenous injection * 0.35 mcg/kg * in two minutes * if shivering 5 minutes after delivery
meperidine	Meperidine Injection	Unique dose of meperidine injection: * intravenous injection * 0.35 mg/kg * in two minutes * if shivering 5 minutes after delivery

Primary Outcome Measures

Name	Time	Method
Stop time	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)

Secondary Outcome Measures

Name	Time	Method
incidence of adverse effects	24 hours	sedation, nausea, vomiting, hypotension and bradycardia
maternal satisfaction	at 24 hours	satisfaction (yes or no) regarding experience with study drug
response rate	15 minutes	percentage of patient responding when the drug is given
cost benefice analysis	24 hours	comparing cost of the drug

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada