Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia

Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial

The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Tremor
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal saline

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

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C4
      • St-Justine's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Cesarean delivery under neuraxial anesthesia (epidural or spinal) planned or unplanned between 8 am and 8 pm on week days when one of the investigator is present.
• Participants with fever or shivering before the cesarean section are include

Exclusion Criteria:

• No comprehension of french or english language
• Urgent cesarean delivery for non reassuring fetal tracing
• Extremely urgent cesarean delivery (grade 1)
• Weight < 60 kg ou > 120 kg
• Hypersensibility to dexmedetomidine
• Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
• Pre-eclampsia
• Combined spinal-epidural anesthesia
• Conversion into general anesthesia
• Blood products transfusions or major complications during surgery

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
Active Comparator: Dexmedetomidine; Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus	Drug: Dexmedetomidine; An intravenous bolus of dexmedetomidine 30 mcg (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.; Other Names: Precedex
Placebo Comparator: Normal saline; NaCl 0,9% 7,5 ml, single intravenous bolus	Drug: Normal saline; An intravenous bolus of normal saline (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.; Other Names: NaCl 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for cessation of shivering after bolus (min)	Graded on a four point scale as per Crossley and Mahajan	Within the first 15 minutes of administration of bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bradycardia	Heart rate below 50 bpm	From the administration of bolus to the end of surgery, an expected average of 1 hour
Incidence of hypotension	A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure	From the administration of bolus to the end of surgery, an expected average of 1 hour
Incidence of sedation	Graded on a four point scale as per Filos et al	From the administration of bolus to the end of surgery, an expected average of 1 hour

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Investigators: Principal Investigator: Christina Lamontagne, MD, St. Justine's Hospital; Study Director: Chantal Crochetière, MD, FRCP, St. Justine's Hospital; Study Chair: Edith Villeneuve, St. Justine's Hospital; Study Chair: Sandra Lesage, St. Justine's Hospital

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.
• 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.
• 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.
• Lamontagne C, Lesage S, Villeneuve E, Lidzborski E, Derstenfeld A, Crochetiere C. Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):762-771. doi: 10.1007/s12630-019-01354-3. Epub 2019 Apr 3.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cesarean section; Dexmedetomidine; Anesthesia, Spinal; Anesthesia, Epidural
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Tremor; 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; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 050115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED