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

NCT06627816 | Completed

• 1 other identifier: N-343-2024
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Nefopam; Dexmeditomidine; Meperidine; Post-spinal Anesthesia Shivering

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• - Intraoperative hemodynamic variables

  120 minutes

• axillary body temperature

  120 minutes

• recurrent shivering

  120 minutes

Study Arms (3)

nefopam group

ACTIVE COMPARATOR

• 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

dexmeditomidine group

ACTIVE COMPARATOR

• 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

meperidine group

ACTIVE COMPARATOR

• Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml).

Drug: Nefopam

Interventions

Nefopam DRUG

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

Also known as: dexmeditomidine, meperidine

dexmeditomidine group; meperidine group; nefopam group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Aini Hospitals

Cairo, Egypt

Location

Related Publications (1)

• Abdelhafez EM, El-Siory W, Turki D, Eissa AA. Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Postspinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study. Anesthesiol Res Pract. 2025 Dec 3;2025:4549345. doi: 10.1155/anrp/4549345. eCollection 2025.

  PMID: 41346412 DERIVED

MeSH Terms

Interventions

Nefopam; Meperidine

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia& ICU

Model Details: comparative study

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: January 10, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 5, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

EG (1)