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

NCT ID: NCT06627816

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-07-05

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.

Conditions

Nefopam; Dexmeditomidine; Meperidine; Post-spinal Anesthesia Shivering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Nefopam

Intervention Type: DRUG

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

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)

Group Type: ACTIVE_COMPARATOR

Nefopam

Intervention Type: DRUG

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

meperidine group

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

Group Type: ACTIVE_COMPARATOR

Nefopam

Intervention Type: DRUG

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

Interventions

Nefopam

efficacy of 3 drugs in preventing post-spinal anesthesia shivering

Intervention Type: DRUG

Other Intervention Names

dexmeditomidine; meperidine

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amany Ahmed Eissa

lecturer of anesthesia& ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Al Aini Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-343-2024

Identifier Type: -

Identifier Source: org_study_id