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

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

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

Conditions
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Tremor

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus | Drug: Dexmedetomidine<br>* 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.<br>* Other names: Precedex;|
| Placebo Comparator: Normal saline<br>NaCl 0,9% 7,5 ml, single intravenous bolus | Drug: Normal saline<br>* 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.<br>* Other names: NaCl 0,9%;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Cesarean section, Anesthesia, Spinal, Anesthesia, Epidural