Dexmeditomidine, Meperidine, Nefopam, Post-spinal Anesthesia Shivering
Conditions
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.
Interventions
DRUGNefopam
efficacy of 3 drugs in preventing post-spinal anesthesia shivering
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention model description
comparative study
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of shivering during the whole observation period | 120 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Intraoperative hemodynamic variables | 120 minutes | \- (HR, MAP, SPO2) every 15 minutes |
| axillary body temperature | 120 minutes | every 30 minutes |
| recurrent shivering | 120 minutes | response to treatment |
Countries
Egypt
Outcome results
None listed