Clinical trial NCT03115047: Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section Complications
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Stop time
timeFrame: 15 minutes
Secondary outcomes:
measure: incidence of adverse effects
timeFrame: 24 hours
measure: maternal satisfaction
timeFrame: at 24 hours
measure: response rate
timeFrame: 15 minutes
measure: cost benefice analysis
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Anne Lavoie, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1097/00000539-200111000-00052.
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.
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. doi: 10.1016/s1098-7339(98)90017-7.
citation: 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.