Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

Saint-Joseph University

Status and phase: Unknown; Phase 4

Conditions: Adverse Effects in the Therapeutic Use of Anaesthetic; Shivering

Treatments: Drug: Nefopam Injectable Solution; Drug: Ondansetron 8mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04870541

HDF15891

Details and patient eligibility

About

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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Patients receiving Ondansetron

Active Comparator group

Treatment:

Drug: Ondansetron 8mg

Patients receiving Nefopam

Active Comparator group

Treatment:

Drug: Nefopam Injectable Solution