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 : January 29, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Centre hospitalier de l'Université de Montréal (CHUM)

Study Description

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.

Study Design

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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 :	January 27, 2021
Estimated Study Completion Date :	January 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Drug Information available for: Meperidine hydrochloride Meperidine Dexmedetomidine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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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

Contacts and Locations

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)

More Information

Publications:

Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. Review.

De Witte J, Sessler DI. Perioperative shivering: physiology and pharmacology. Anesthesiology. 2002 Feb;96(2):467-84. Review.

Kranke P, Eberhart LH, Roewer N, Tramèr MR. Pharmacological treatment of postoperative shivering: a quantitative systematic review of randomized controlled trials. Anesth Analg. 2002 Feb;94(2):453-60, table of contents.

Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.

Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92.

Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031.

Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998 Jul-Aug;23(4):418-23.

Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7.

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Responsible Party:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT03115047
Other Study ID Numbers:	2017-7124
First Posted:	April 14, 2017 Key Record Dates
Last Update Posted:	January 29, 2020
Last Verified:	January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

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