Prevention of Post-Operative Shivering

NCT04682743 | Completed Early Phase 1 DMC

• 1 other identifier: N-122-2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Shivering

Outcome Measures

Primary Outcomes (1)

• Incidence of shivering

  60 min postoperatively

  UP TO 1 HOURE

Secondary Outcomes (2)

• The assessment the core temperatures

  UP TO 24 HOURE

• postoperative shivering scores

  up to 2 hours

Study Arms (3)

saline group

SHAM COMPARATOR

Drug: normal saline

ondansetron group

ACTIVE COMPARATOR

Drug: ondansetron

paracetamol group

ACTIVE COMPARATOR

Drug: paracetamol

Interventions

paracetamol DRUG

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

paracetamol group

ondansetron DRUG

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

ondansetron group

normal saline DRUG

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

saline group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Acetaminophen; Ondansetron; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: January 6, 2021
• Primary Completion: January 16, 2022
• Study Completion: February 22, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

EG (1)