Menu
Not yet recruiting NCT07377903

Post Operative Shivering Following Anesthesia

No phase Interventional Shivering, Spinal Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidin, Mg (magnesium sulfate), Ondansetron 8 mg.
Who it may be relevant to
Registry conditions: Shivering, Spinal Anesthesia. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pharmacological Management of Post Operative Shivering Following Anesthesia

Overview

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

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.

Interventions

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

Primary outcome measures

  • Time to cessation of shivering after drug administration. [Time frame: 6 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377903 · Soh_med__25_12_10MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗