Clinical trial NCT06627816: Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nefopam
Dexmeditomidine
Meperidine
Post-spinal Anesthesia Shivering
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: the incidence of shivering during the whole observation period
timeFrame: 120 minutes
Secondary outcomes:
measure: - Intraoperative hemodynamic variables
timeFrame: 120 minutes
measure: axillary body temperature
timeFrame: 120 minutes
measure: recurrent shivering
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Aini Hospitals
Study officials:
References: