Prevention of Post-Operative Shivering

Study Overview
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Brief Summary
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Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia. paracetamol is an antipyretic drug that has been in clinical use for a long time. It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.

Official Title
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Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering

Conditions
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Post-Operative Shivering

Intervention / Treatment
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* Drug: paracetamol
* Drug: ondansetron
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients between 18-40 years. ASA physical status I and II Both genders Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia Exclusion criteria Patients who refused to participate in the study, ASA physical status more than II, any contraindications to regional anesthesia, surgical duration less than two hours or exceeding six hours, giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders, any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation, Finally if their body temperature was recorded to surpass 37.5ºC or <36.5°C before enrolment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: saline group<br> | Drug: normal saline<br>* received intravenous 0.9% normal saline over a 15-minute period.<br>|
| Active Comparator: ondansetron group<br> | Drug: ondansetron<br>* received intravenous 8 mg of ondansetron over a 15-minute period.<br>|
| Active Comparator: paracetamol group<br> | Drug: paracetamol<br>* received intravenous one gram of paracetamol over a 15-minute period,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of shivering | 60 min postoperatively | UP TO 1 HOURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The assessment the core temperatures | temperatures | UP TO 24 HOURE | 
| postoperative shivering scores | 0 indicated no shivering; 1, piloerection or peripheral vasoconstriction, but no visible shivering; 2, muscular activity in only 1 muscle group; 3, muscular activity in >1 muscle group, but not generalized; and 4, shivering involving the whole body. | up to 2 hours |