Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Study Overview
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Brief Summary
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Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.

Detailed Description
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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.

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

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Dexmedetomidine Injection
* Drug: Meperidine Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>Unique dose of dexmedetomidine injection: intravenous injection 0.35 mcg/kg in two minutes if shivering 5 minutes after delivery | Drug: Dexmedetomidine Injection<br>* 0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery<br>* Other names: precedex;|
| Active Comparator: meperidine<br>Unique dose of meperidine injection: intravenous injection 0.35 mg/kg in two minutes if shivering 5 minutes after delivery | Drug: Meperidine Injection<br>* 0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery<br>* Other names: demerol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 15 minutes | 

Secondary Outcome Measures

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