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

Kasr El Aini Hospital

Status: Completed

Conditions: Nefopam; Meperidine; Dexmeditomidine; Post-spinal Anesthesia Shivering

Treatments: Drug: Nefopam

Study type: Interventional

Funder types: Other

Identifiers

NCT06627816

N-343-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups

nefopam group

Active Comparator group

Description:

• 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)

Treatment:

Drug: Nefopam

dexmeditomidine group

Active Comparator group

Description:

• Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml)

Treatment:

Drug: Nefopam

meperidine group

Active Comparator group

Description:

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

Treatment:

Drug: Nefopam