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Completed

NCT Number: NCT06627816

Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries.

This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al Aini Hospitals

Cairo, Egypt

About this study

Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
  • ASA physical status I and II.

Exclusion criteria

  • • Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.
  • Thyroid disorders, psychiatric disorders, severe diabetes, or autonomic neuropathies
  • Known history of substance or alcohol abuse
  • A history of convulsive disorders or severe neurological diseases
  • Severe cardiac, pulmonary, renal, or hepatic disease
  • Obstetric procedures and procedures requiring transfusion of blood and blood products.
  • A contraindication to spinal anesthesia, e.g., coagulation disorders, local or general infection, increased intracranial tension, and progressive neurological disorders.
  • Failed or partial spinal block.

Treatment and study plan

Nefopam

Drug

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

Other names: dexmeditomidine, meperidine

Primary outcomes

  1. the incidence of shivering during the whole observation period

    Time frame: 120 minutes

    shivering score ≥ 3. The shivering score will be assessed at 10-minute intervals after the spinal block and graded by the scale validated by Wrench et al.

Secondary outcomes

  1. - Intraoperative hemodynamic variables

    Time frame: 120 minutes

    • (HR, MAP, SPO2) every 15 minutes
  2. axillary body temperature

    Time frame: 120 minutes

    every 30 minutes

  3. recurrent shivering

    Time frame: 120 minutes

    response to treatment

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Jul 10, 2025

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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