Post Operative Shivering Following Anesthesia

February 1, 2026 updated by: Aya Muhammad Aboelwafa, Sohag University

Pharmacological Management of Post Operative Shivering Following Anesthesia

The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ ) and the recurrence of shivering

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized double blinded study including patients undergoing surgery under spinal anesthesia. Patients will be randomly allocated into three groups to receive magnesium sulphate, ondansetron, or dexmedetomidine for the treatment of post-spinal anesthesia shivering. The time to cessation of shivering, hemodynamic parameters, and recurrence of shivering will be recorded.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Elsaied Abd Elrahman, Professor
  • Phone Number: 01095848062 01118011611
  • Email: elsaiedsoon@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age from 18 to 45 years.
  • Both sexes.
  • American Society of Anesthesiologists physical status I, II
  • Scheduled for elective lower abdominal or lower limb surgeries under spinal anesthesia

Exclusion Criteria:

  • Patients with known allergy to study drugs.
  • Patients with baseline body temperature outside the normal range (36-37.5°C).
  • History of thermoregulatory disorders, thyroid dysfunction, or neurological diseases.
  • Patients receive sedatives, antipsychotics, or antidepressants.
  • Patients require intraoperative conversion to general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine group
Drug: Dexmedetomidin
•Group D (Dexmedetomidine Group): 0.5 µg/kg dexmedetomidine diluted in 100 mL of normal saline.
Experimental: Mg sulphate group
50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.
Drug: Mg (magnesium sulfate)
50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.
Experimental: ondansetron group
Drug: Ondansetron 8 mg
8 mg ondansetron diluted in 100 mL of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to cessation of shivering after drug administration.
Time Frame: 6 hours

Grade 0: No shivering.

  • Grade 1: Piloerection or peripheral vasoconstriction but no visible shivering. 4
  • Grade 2: Muscular activity in only one muscle group.
  • Grade 3: Muscular activity in more than one muscle group.
  • Grade 4: Whole-body shivering.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh_med__25_12_10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding sharing individual participant data has not yet been made. This will depend on future agreements, ethical approvals, and data governance policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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