Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

Study Overview
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Brief Summary
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Spinal anesthesia affects the homeostatic systems resulting in intraoperative hypothermia and subsequently shivering. In fact, shivering may be seen after this technique in 30 to 40% of cases . Ondansetron and Nefopam have been used to prevent intraoperative shivering . However, no prospective, randomized, double-blind study has been conducted to this date in order to compare nefopam with ondansetron in the prevention of post-spinal anesthesia shivering. The primary objective of this prospective, randomized, double-blind study is to compare the incidence and intensity of shivering after spinal anesthesia for non-obstetric surgery in 2 groups of patients. Group A: Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients). • Group B: Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)

Official Title
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Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.

Conditions
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Shivering, Adverse Effects in the Therapeutic Use of Anaesthetic

Intervention / Treatment
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* Drug: Ondansetron 8mg
* Drug: Nefopam Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 65 years scheduled for a surgery under spinal anesthesia Exclusion Criteria: pregnant or breastfeeding (for the women), if they are Allergy to any of the drugs to be used Long QT syndrome Hepatic insufficiency Renal failure Parkinson's disease Epilepsy Glaucoma Phenylketonuria

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: Patients receiving Ondansetron<br> | Drug: Ondansetron 8mg<br>* Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).<br>|
| Active Comparator: Patients receiving Nefopam<br> | Drug: Nefopam Injectable Solution<br>* Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of shivering | Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes. | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. | 
| Grade of shivering | Grades of shivering will be noted every 15 minutes from drug administration up to 120 minutes. Shivering will be graded : 0 = no shivering, 1= piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body. | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea/Vomitting | Number of episodes of nausea and/or vomiting during and after surgery. | Every 15 minutes from drug administration up to 120 minutes | 
| Hypotention/Bradycardia | Hypotention: Number of episodes of hypotension SBP <90mmhg or <25% of baseline SBP in post spinal anesthesia until discharge from the PACU. Bradycardia: Number of episodes of bradycardia <50 / min post-spinal anesthesia until discharge from the PACU. | Every three minutes from drug administration up to 120 minutes. | 
| Pain on injection site by analogue visual scale. | Pain upon administration of drug on site of injection will be assessed using the analogue visual scale . | During administration of drug. |