Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

Last updated: April 28, 2021
Sponsor: Saint-Joseph University
Overall Status: Active - Recruiting

Phase

4

Condition

Essential Tremor

Treatment

N/A

Clinical Study ID

NCT04870541
HDF15891
  • Ages 18-65
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age between 18 and 65 years
  • scheduled for a surgery under spinal anesthesia

Exclusion

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

Study Design

Total Participants: 150
Study Start date:
December 01, 2020
Estimated Completion Date:
December 01, 2021

Connect with a study center

  • Universite Saint Joseph , Hotel Dieu de France

    Beirut,
    Lebanon

    Active - Recruiting

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