Prevention of Post-Operative Shivering

Early Phase 1CompletedNCT04682743

Cairo University120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Post-Operative Shivering

Interventions

paracetamolDRUG

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

ondansetronDRUG

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

normal salineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Incidence of shivering

60 min postoperatively

Time frame: UP TO 1 HOURE

Secondary Outcomes

The assessment the core temperatures

temperatures

Time frame: 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.

Time frame: up to 2 hours

Data from ClinicalTrials.gov

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