Prevention of Post-Operative Shivering

NCT ID: NCT04682743

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-02-22

Brief Summary

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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

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Conditions

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Post-Operative Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline group

Group Type SHAM_COMPARATOR

normal saline

Intervention Type DRUG

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

ondansetron group

Group Type ACTIVE_COMPARATOR

ondansetron

Intervention Type DRUG

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

paracetamol group

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

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

Interventions

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paracetamol

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

Intervention Type DRUG

ondansetron

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-122-2020

Identifier Type: -

Identifier Source: org_study_id

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