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
Mongi Slim Hospital
300 participants
Nov 30, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria4
- All patients who required :
- more than two attempts for spinal anaesthesia
- conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
- As well as patients who have subsequently withdrawn their consent for participating to our study.
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Interventions
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06444737