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

St. Justine's Hospital

Status and phase: Completed; Phase 3

Conditions: Tremor

Treatments: Drug: Normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02384343

050115

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline