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Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

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ClinicalTrials.gov Identifier: NCT03115047
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: Dexmedetomidine Injection Drug: Meperidine Injection Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded randomized study: meperidine and dexmedetomidine will be prepared at the hospital pharmacy in a 10 mL seringue with equivalent dilution in order to gave mL/kg.
Primary Purpose: Treatment
Official Title: Traitement Des Frissons Lors de la césarienne Sous anesthésie péridurale Durant le Travail - un Essai Clinique randomisé Comparant la dexmédétomidine et la mépéridine
Actual Study Start Date : May 7, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: dexmedetomidine

Unique dose of dexmedetomidine injection:

  • intravenous injection
  • 0.35 mcg/kg
  • in two minutes
  • if shivering 5 minutes after delivery
Drug: Dexmedetomidine Injection
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Other Name: precedex

Active Comparator: meperidine

Unique dose of meperidine injection:

  • intravenous injection
  • 0.35 mg/kg
  • in two minutes
  • if shivering 5 minutes after delivery
Drug: Meperidine Injection
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Other Name: demerol




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Parturient, after cesarean delivery
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115047


Contacts
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Contact: Anne Lavoie, MD, FRCPC 514-890-8358 anne.lavoie@umontreal.ca
Contact: Gabriel Paquin-Lanthier, MD 514-445-2383 gabriel.paquin-lanthier@umontreal.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3J4
Contact: Gabriel Paquin-Lanthier, MD    514-445-2383    gabriel.paquin-lanthier@umontreal.ca   
Principal Investigator: Anne Lavoie, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Anne Lavoie, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)

Publications:
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03115047     History of Changes
Other Study ID Numbers: 2017-7124
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Meperidine
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia