Prevention of Post-Operative Shivering

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04682743
Collaborator
(none)
120
1
3
13.5
8.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering
Actual Study Start Date :
Jan 6, 2021
Actual Primary Completion Date :
Jan 16, 2022
Actual Study Completion Date :
Feb 22, 2022

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

  1. Incidence of shivering [UP TO 1 HOURE]

    60 min postoperatively

Secondary Outcome Measures

  1. The assessment the core temperatures [UP TO 24 HOURE]

    temperatures

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University
ClinicalTrials.gov Identifier:
NCT04682743
Other Study ID Numbers:
  • N-122-2020
First Posted:
Dec 24, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022