Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

NCT03115047 | Completed Phase 3

• 1 other identifier: 2017-7124
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• incidence of adverse effects

  24 hours

• maternal satisfaction

  at 24 hours

• response rate

  15 minutes

• cost benefice analysis

  24 hours

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

Unique dose of dexmedetomidine injection: * intravenous injection * 0.35 mcg/kg * in two minutes * if shivering 5 minutes after delivery

Drug: Dexmedetomidine Injection

meperidine

ACTIVE COMPARATOR

Unique dose of meperidine injection: * intravenous injection * 0.35 mg/kg * in two minutes * if shivering 5 minutes after delivery

Drug: Meperidine Injection

Interventions

Dexmedetomidine Injection DRUG

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

Also known as: precedex

dexmedetomidine

Meperidine Injection DRUG

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

Also known as: demerol

meperidine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Parturient, after cesarean delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J4, Canada

Location

Related Publications (8)

• 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.

  PMID: 18433676 BACKGROUND

• 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.

  PMID: 11818783 BACKGROUND

• 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.

  PMID: 11812718 BACKGROUND

• 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.

  PMID: 27228512 BACKGROUND

• 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.

  PMID: 11682416 BACKGROUND

• 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.

  PMID: 25024466 BACKGROUND

• 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.

  PMID: 9690596 BACKGROUND

• 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.

  PMID: 8147511 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Meperidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines

Study Officials

• Anne Lavoie, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 14, 2017
• Study Start: May 7, 2017
• Primary Completion: August 19, 2020
• Study Completion: August 20, 2020
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)