Prevention of Post-Operative Shivering

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Operative Shivering
• Intervention / Treatment: Drug: normal saline; Drug: ondansetron; Drug: paracetamol

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): January 16, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Acetaminophen; Ondansetron
• Other Study ID Numbers: N-122-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No