Prevention of Post-Operative Shivering

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04682743

Enrollment

120

Registered

2020-12-24

Start date

2021-01-06

Completion date

2022-02-22

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Operative Shivering

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.

Interventions

DRUGparacetamol

received intravenous one gram of paracetamol over a 15-minute period,

DRUGondansetron

received intravenous 8 mg of ondansetron over a 15-minute period.

DRUGnormal saline

received intravenous 0.9% normal saline over a 15-minute period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of shivering	UP TO 1 HOURE	60 min postoperatively

Secondary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026