The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Study Overview
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Brief Summary
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The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.

Detailed Description
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The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride. Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received. Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.

Official Title
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The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia

Conditions
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Perioperative/Postoperative Complications

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine
* Drug: sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 y/o patients American Society of Anesthesiologists' physical status class I-II Scheduled for the spinal anesthesia Exclusion Criteria: Patients who have the body temperature over 37.3 celsius degree Pregnants Known allergies to the study drugs Contraindication to spinal anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous<br>Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) | Drug: Levobupivacaine<br>* Intrathecal 3ml (15 mg)<br>* Other names: Chirocaine, 0.5%, 10 ml, Abbott;Drug: Dexmedetomidine<br>* Intrathecal 3 microgram (diluted 1/10, 0.3 ml)<br>* Other names: Precedex, 100 mcg/ml, Abbott;Drug: sodium chloride<br>* Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.<br>* Other names: 0.9 Sodium chloride;|
| Active Comparator: Intrathecal<br>Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) | Drug: Levobupivacaine<br>* Intrathecal 3ml (15 mg)<br>* Other names: Chirocaine, 0.5%, 10 ml, Abbott;Drug: Dexmedetomidine<br>* Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)<br>* Other names: Precedex, 100 mcg/ml, Abbott;Drug: sodium chloride<br>* Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.<br>* Other names: 0.9 Sodium chloride;|
| Placebo Comparator: Control<br>Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion). | Drug: Levobupivacaine<br>* Intrathecal 3ml (15 mg)<br>* Other names: Chirocaine, 0.5%, 10 ml, Abbott;Drug: sodium chloride<br>* Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.<br>* Other names: 0.9 Sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shivering score |  | 1 day (From start of anaesthesia till discharge from the recovery room ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | non invasive blood pressure measured | 1 day (From start of anaesthesia till discharge from the recovery room ) | 
| heart rate |  | 1 day (From start of anaesthesia till discharge from the recovery room ) | 
| core temperature | lower than 36 celsius degree was accepted as hypothermia | 1 day (From start of anaesthesia till discharge from the recovery room ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shivering, Dexmedetomidine, Spinal anesthesia