Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Cesarean Section Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115047
• Other study ID #: 2017-7124
• Status: Completed
• Phase: Phase 3
• Start date: May 7, 2017
• Est. completion date: August 20, 2020

Study information

• Verified date: May 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 20, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Dexmedetomidine Injection
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
• Meperidine Injection
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of adverse effects	sedation, nausea, vomiting, hypotension and bradycardia	24 hours
Secondary	maternal satisfaction	satisfaction (yes or no) regarding experience with study drug	at 24 hours
Secondary	response rate	percentage of patient responding when the drug is given	15 minutes
Secondary	cost benefice analysis	comparing cost of the drug	24 hours