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NCT Number: NCT07377903

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Dexmedetomidin

Drug

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

Mg (magnesium sulfate)

Drug

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

Ondansetron 8 mg

Drug

8 mg ondansetron diluted in 100 mL of normal saline.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Elsaied Abd Elrahman, Professor

CONTACT

[email protected]

01118011611 ext. 01095848062

Aya Mohammed Aboelwafa, Resident of anesthesia

CONTACT

[email protected]

01095848062 ext. 01002181828

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Pharmacological Management of Post Operative Shivering Following Anesthesia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Feb 4, 2026

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.

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