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

Phase 3

Completed

• Conditions: Tremor
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine

• Registration Number: NCT02384343
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Study Start: 2015-04
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	NaCl 0,9% 7,5 ml, single intravenous bolus
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of hypotension	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
Incidence of sedation	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
Incidence of bradycardia	From the administration of bolus to the end of surgery, an expected average of 1 hour	Heart rate below 50 bpm

Trial Locations

Locations (1)

St-Justine's Hospital; 🇨🇦 Montréal, Quebec, Canada