Preventing shivering after spinal anesthesia using nefopam, dexmedetomidine, and meperidine
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
This study is testing whether nefopam, dexmedetomidine, or meperidine can help prevent shivering in adults after they receive spinal anesthesia for lower abdominal and leg surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06627816 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized, controlled, double-blinded study evaluates the effectiveness of nefopam in comparison to dexmedetomidine and meperidine for preventing post-spinal anesthesia shivering in adult patients undergoing lower abdominal and lower limb surgeries. The study aims to minimize side effects while assessing the efficacy of these medications. Previous studies have shown nefopam to be effective in treating postoperative shivering, and this research seeks to further explore its benefits specifically after neuraxial blockades.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
Not a fit: Patients with known hypersensitivity to the study medications or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer option for preventing shivering in patients after spinal anesthesia.
How similar studies have performed: Previous studies have shown success with nefopam in preventing postoperative shivering, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Kasr Al Aini Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Amany A Eissa, lecturer
- Email: Amany.Eissa@kasralainy.edu.eg
- Phone: 002-01001807207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.