Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Dexmedetomidine Injection; Drug: Meperidine Injection

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: demerol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Anne Lavoie, MD, FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Publications and helpful links

General 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.
• De Witte J, Sessler DI. Perioperative shivering: physiology and pharmacology. Anesthesiology. 2002 Feb;96(2):467-84. doi: 10.1097/00000542-200202000-00036. No abstract available.
• Kranke P, Eberhart LH, Roewer N, Tramer 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. doi: 10.1097/00000539-200202000-00043.
• 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. doi: 10.1097/00000539-200111000-00052.
• 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. doi: 10.1016/s1098-7339(98)90017-7.
• Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2017
• Primary Completion (Actual): August 19, 2020
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: April 8, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Meperidine
• Other Study ID Numbers: 2017-7124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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