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

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

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.

Study Overview

• Status: Completed
• Conditions: Meperidine; Nefopam; Dexmeditomidine; Post-spinal Anesthesia Shivering
• Intervention / Treatment: Drug: Nefopam

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Al Aini Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nefopam group; • 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)	Drug: Nefopam; efficacy of 3 drugs in preventing post-spinal anesthesia shivering; Other Names: meperidine; dexmeditomidine
Active Comparator: dexmeditomidine group; • Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml)	Drug: Nefopam; efficacy of 3 drugs in preventing post-spinal anesthesia shivering; Other Names: meperidine; dexmeditomidine
Active Comparator: meperidine group; • Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml).	Drug: Nefopam; efficacy of 3 drugs in preventing post-spinal anesthesia shivering; Other Names: meperidine; dexmeditomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of shivering during the whole observation period	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.	120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 5, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Meperidine; Nefopam
• Other Study ID Numbers: N-343-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No