Prevention of Post-Operative Shivering

Early Phase 1

Completed

• Conditions: Post-Operative Shivering
• Interventions: Drug: normal saline; Drug: paracetamol; Drug: ondansetron

• Registration Number: NCT04682743
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-24
• Study Start: 2021-01-06
• Primary Completion: 2022-01-16
• Study Completion: 2022-02-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline group	normal saline	-
paracetamol group	paracetamol	-
ondansetron group	ondansetron	-

Primary Outcome Measures

Name	Time	Method
Incidence of shivering	UP TO 1 HOURE	60 min postoperatively

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt