Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3J4, Canada
NCT Number: NCT03115047
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
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Notify Me18 year–45 year
Female
Interventional
Phase 3
Montreal, Quebec, H2X 3J4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Other names: precedex
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Other names: demerol
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)
Time frame: 24 hours
sedation, nausea, vomiting, hypotension and bradycardia
Time frame: at 24 hours
satisfaction (yes or no) regarding experience with study drug
Time frame: 15 minutes
percentage of patient responding when the drug is given
Time frame: 24 hours
comparing cost of the drug
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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