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

Not Applicable

Recruiting

• Conditions: Nefopam; Dexmeditomidine; Meperidine; Post-spinal Anesthesia Shivering
• Interventions: Drug: Nefopam

• Registration Number: NCT06627816
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Study Start: 2025-01-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nefopam group	Nefopam	• Group N (n=80) will receive nefopam 0.15 mg/kg i.v. (Nopain®, Medical Union Pharmaceuticals MUP, Ismailia, Egypt, Ampoules of 20 mg/1 ml)
dexmeditomidine group	Nefopam	• Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml)
meperidine group	Nefopam	• Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml).

Primary Outcome Measures

Name	Time	Method
the incidence of shivering during the whole observation period	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 Outcome Measures

Name	Time	Method
- Intraoperative hemodynamic variables	120 minutes	- (HR, MAP, SPO2) every 15 minutes
axillary body temperature	120 minutes	every 30 minutes
recurrent shivering	120 minutes	response to treatment

Trial Locations

Locations (1)

Kasr Al Aini Hospitals; 🇪🇬 Cairo, Egypt