Post Operative Shivering Following Anesthesia

NCT07377903 | Not Yet Recruiting DMC

• 1 other identifier: Soh_med__25_12_10MS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Shivering, Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to cessation of shivering after drug administration.

  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

Study Arms (3)

Mg sulphate group

EXPERIMENTAL

50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.

Drug: Mg (magnesium sulfate)

dexmedetomidine group

EXPERIMENTAL

Drug: Dexmedetomidin

ondansetron group

EXPERIMENTAL

Drug: Ondansetron 8 mg

Interventions

Ondansetron 8 mg DRUG

8 mg ondansetron diluted in 100 mL of normal saline.

ondansetron group

Dexmedetomidin DRUG

•Group D (Dexmedetomidine Group): 0.5 µg/kg dexmedetomidine diluted in 100 mL of normal saline.

dexmedetomidine group

Mg (magnesium sulfate) DRUG

50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.

Mg sulphate group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate; Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Aya Mohammed Aboelwafa, Resident of anesthesia

CONTACT

01095848062; aya_muhammad_post@med.sohag.edu.eg

Ahmed Elsaied Abd Elrahman, Professor

CONTACT

01118011611; elsaiedsoon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anesthesia and surgical intensive care unit and pain management

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01