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Completed

NCT Number: NCT02384343

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

St-Justine's Hospital

Montreal, Quebec, H3T 1C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Precedex

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.

Other names: NaCl 0,9%

Primary outcomes

  1. Time for cessation of shivering after bolus (min)

    Time frame: Within the first 15 minutes of administration of bolus

    Graded on a four point scale as per Crossley and Mahajan

Secondary outcomes

  1. Incidence of bradycardia

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

    Heart rate below 50 bpm

  2. Incidence of hypotension

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

    A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure

  3. Incidence of sedation

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

    Graded on a four point scale as per Filos et al

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2015
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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