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Completed

NCT Number: NCT03115047

Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injection

Drug

0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery

Other names: precedex

Meperidine Injection

Drug

0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery

Other names: demerol

Primary outcomes

  1. 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)

Secondary outcomes

  1. incidence of adverse effects

    Time frame: 24 hours

    sedation, nausea, vomiting, hypotension and bradycardia

  2. maternal satisfaction

    Time frame: at 24 hours

    satisfaction (yes or no) regarding experience with study drug

  3. response rate

    Time frame: 15 minutes

    percentage of patient responding when the drug is given

  4. cost benefice analysis

    Time frame: 24 hours

    comparing cost of the drug

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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