Dexmedetomidine in Post Spinal Anesthesia Shivering

Study Overview
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Brief Summary
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This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.

Detailed Description
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Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression. Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.

Official Title
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Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Clinically Controlled Dose-finding Study.

Conditions
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Shivering Caused by Spinal Anesthesia

Intervention / Treatment
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* Drug: Pethidine 0.4mg/kg
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of >60 and <180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period Exclusion Criteria: Patients with BMI>30 kg /m2 Initial body temperature >38 C or <36 C and those with a history of convulsions Multiple allergies Thyroid disease Parkinson's disease Dysautonomia Raynaud's syndrome Hypertension Coronary artery disease or other cardio-respiratory or neuromuscular pathology Middle ear pathology A known history of alcohol use Treatment with sedative hypnotic agents or vasodilators Having contraindications to spinal anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pethidine 0.4mg/kg iv<br>interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished. | Drug: Pethidine 0.4mg/kg<br>* 2ml intravenous bolus slowly injected in 2minutes.<br>* Other names: Meperidine;|
| Active Comparator: DEX. I<br>Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished. | Drug: Dexmedetomidine<br>* 2ml intravenous bolus slowly injected in 2minutes<br>* Other names: Precedex;|
| Active Comparator: DEX. II<br>Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. | Drug: Dexmedetomidine<br>* 2ml intravenous bolus slowly injected in 2minutes<br>* Other names: Precedex;|
| Active Comparator: DEX III<br>Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. | Drug: Dexmedetomidine<br>* 2ml intravenous bolus slowly injected in 2minutes<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shivering response rate (%) | complete cessation of shivering activity within 10 minutes after study drug injection | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | find for systolic hypotension, hypertension | 6 hours after study drug injection | 
| sedation | using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking). | 6 hours after study drug injection | 
| peripheral arterial saturation | find for hypoxia | 6 hours after study drug injection | 
| diastolic blood pressure | find for diastolic hypertension or hypotension | 6 hours after study drug injection | 
| Postoperative adverse events | postoperative nausea and vomiting, urine retention, post dural puncture headache ect. | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal, Anesthesia, dexmedetomidine, pethidine, shivering