Actively Recruiting
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
Led by Mongi Slim Hospital · Updated on 2024-06-06
300
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- More than two attempts required for spinal anaesthesia
- Conversion to general anesthesia due to spinal anesthesia failure (sensory block level <T6) or intraoperative complications such as hemorrhage or anaphylactic shock
- Withdrawal of consent for participation in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mongi slim hospital
Tunis, Tunisia, 2085
Actively Recruiting
Research Team
M
Mhamed Sami Mebazaa, professor
CONTACT
A
Amani Ben Haj Youssef, assistant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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