Overview
Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.
Status:
Recruiting
Recruiting
Trial end date:
2021-12-01
2021-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Spinal anesthesia affects the homeostatic systems resulting in intraoperative hypothermia and subsequently shivering. In fact, shivering may be seen after this technique in 30 to 40% of cases . Ondansetron and Nefopam have been used to prevent intraoperative shivering . However, no prospective, randomized, double-blind study has been conducted to this date in order to compare nefopam with ondansetron in the prevention of post-spinal anesthesia shivering. The primary objective of this prospective, randomized, double-blind study is to compare the incidence and intensity of shivering after spinal anesthesia for non-obstetric surgery in 2 groups of patients. Group A: Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients). • Group B: Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Saint-Joseph UniversityTreatments:
Nefopam
Ondansetron
Criteria
Inclusion Criteria:- age between 18 and 65 years
- scheduled for a surgery under spinal anesthesia
Exclusion Criteria:
- pregnant or breastfeeding (for the women), if they are
- Allergy to any of the drugs to be used
- Long QT syndrome
- Hepatic insufficiency
- Renal failure
- Parkinson's disease
- Epilepsy
- Glaucoma
- Phenylketonuria