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

NCT02384343 | Completed Phase 3

• 1 other identifier: 050115
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tremor

Keywords

Dexmedetomidine; Cesarean section; Anesthesia, Spinal; Anesthesia, Epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of bradycardia

  From the administration of bolus to the end of surgery, an expected average of 1 hour

• Incidence of hypotension

  From the administration of bolus to the end of surgery, an expected average of 1 hour

• Incidence of sedation

  From the administration of bolus to the end of surgery, an expected average of 1 hour

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus

Drug: Dexmedetomidine

Normal saline

PLACEBO COMPARATOR

NaCl 0,9% 7,5 ml, single intravenous bolus

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

Normal saline DRUG

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.

Also known as: NaCl 0,9%

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St-Justine's Hospital

Montreal, Quebec, H3T 1C4, Canada

Location

Related Publications (4)

• 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

• 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

• 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

• 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.

  PMID: 30945105 DERIVED

MeSH Terms

Conditions

Tremor

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christina Lamontagne, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Chantal Crochetière, MD, FRCP

  St. Justine's Hospital

  STUDY DIRECTOR

• Edith Villeneuve

  St. Justine's Hospital

  STUDY CHAIR

• Sandra Lesage

  St. Justine's Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

CA (1)