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OpenTrials
Completed

NCT Number: NCT04682743

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.

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Key information

Conditions

Post-Operative Shivering

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cairo university

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol

Drug

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

ondansetron

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Incidence of shivering

    Time frame: UP TO 1 HOURE

    60 min postoperatively

Secondary outcomes

  1. The assessment the core temperatures

    Time frame: UP TO 24 HOURE

    temperatures

  2. postoperative shivering scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 24, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.