NCT06444737

Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia

Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mongi Slim Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups: Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia OBJECTIVE : To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

Detailed description

Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications. Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%. OBJECTIVE : To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section. the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024. the investigators included in the study all parturients: * Aged between 18-45 years * ASA 2 * Between 37 and 41 weeks of gestation * scheduled for elective caesarean delivery under spinal anaesthesia * To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification. The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers. were assigned to one of the two parallel groups to receive either : * Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron) * Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)

Conditions

• Post-Dural Puncture Headache

Interventions

Type	Name	Description
DRUG	Intravenous ondansetron	Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
DRUG	Intravenous normal saline	Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-06-30
• Completion: 2024-08-30
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: Tunisia