NCT03115047

Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Injection	0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
DRUG	Meperidine Injection	0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery

Timeline

• Start date: 2017-05-07
• Primary completion: 2020-08-19
• Completion: 2020-08-20
• First posted: 2017-04-14
• Last updated: 2022-05-27

Locations

1 site across 1 country: Canada