Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

Phase 4

• Conditions: Adverse Effects in the Therapeutic Use of Anaesthetic; Shivering
• Interventions: Drug: Ondansetron 8mg; Drug: Nefopam Injectable Solution

• Registration Number: NCT04870541
• Lead Sponsor: Saint-Joseph University

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-03-30
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-05-03
• Last Update Posted: 2021-05-03
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving Ondansetron	Ondansetron 8mg	-
Patients receiving Nefopam	Nefopam Injectable Solution	-

Primary Outcome Measures

Name	Time	Method
Incidence of shivering	Shivering score was noted every 15 minutes from drug administration up to 120 minutes.	Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.
Grade of shivering	Shivering score was noted every 15 minutes from drug administration up to 120 minutes.	Grades of shivering will be noted every 15 minutes from drug administration up to 120 minutes. Shivering will be graded : 0 = no shivering, 1= piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body.

Secondary Outcome Measures

Name	Time	Method
Hypotention/Bradycardia	Every three minutes from drug administration up to 120 minutes.	Hypotention: Number of episodes of hypotension SBP \<90mmhg or \<25% of baseline SBP in post spinal anesthesia until discharge from the PACU.; Bradycardia: Number of episodes of bradycardia \<50 / min post-spinal anesthesia until discharge from the PACU.
Pain on injection site by analogue visual scale.	During administration of drug.	Pain upon administration of drug on site of injection will be assessed using the analogue visual scale .
Nausea/Vomitting	Every 15 minutes from drug administration up to 120 minutes	Number of episodes of nausea and/or vomiting during and after surgery.

Trial Locations

Locations (1)

Universite Saint Joseph , Hotel Dieu de France; 🇱🇧 Beirut, Lebanon