Prevention of Post-Operative Shivering
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Sham Comparator: saline group
|
Drug: normal saline
received intravenous 0.9% normal saline over a 15-minute period.
|
Active Comparator: ondansetron group
|
Drug: ondansetron
received intravenous 8 mg of ondansetron over a 15-minute period.
|
Active Comparator: paracetamol group
|
Drug: paracetamol
received intravenous one gram of paracetamol over a 15-minute period,
|
Outcome Measures
Primary Outcome Measures
- Incidence of shivering [UP TO 1 HOURE]
60 min postoperatively
Secondary Outcome Measures
- The assessment the core temperatures [UP TO 24 HOURE]
temperatures
- postoperative shivering scores [up to 2 hours]
"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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients between 18-40 years.
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ASA physical status I and II
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Both genders
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Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia
Exclusion criteria
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Patients who refused to participate in the study,
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ASA physical status more than II,
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any contraindications to regional anesthesia,
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surgical duration less than two hours or exceeding six hours,
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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,
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any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
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Finally if their body temperature was recorded to surpass 37.5ºC or <36.5°C before enrolment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cairo university | Cairo | Egypt | 11562 |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N-122-2020