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Search / Trial NCT06444737

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

Launched by MONGI SLIM HOSPITAL · Jun 5, 2024

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called ondansetron can help prevent headaches that sometimes occur after a procedure known as spinal anesthesia, which is often used during cesarean deliveries. The trial involves women aged 18 to 45 who are scheduled for an elective cesarean section and are in their late pregnancy (between 37 and 41 weeks). Eligible participants will be randomly assigned to one of two groups: one group will receive ondansetron, and the other will receive a placebo, which is just a saltwater solution.

If you decide to participate, you can expect to receive either the medication or the placebo shortly before the spinal anesthesia is given. The goal is to see if ondansetron can effectively reduce the chances of developing a headache afterward. It's important to note that women who have had difficulty with spinal anesthesia or complications during the procedure will not be included in this study. Overall, this trial aims to improve the experience of women undergoing cesarean sections by potentially reducing the risk of postoperative headaches.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • * 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  • As well as patients who have subsequently withdrawn their consent for participating to our study.

About Mongi Slim Hospital

Mongi Slim Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and a multidisciplinary approach, the hospital fosters a collaborative environment for researchers and healthcare professionals. By conducting rigorous and ethically sound clinical studies, Mongi Slim Hospital aims to contribute to the development of new therapies and treatment protocols, ensuring that cutting-edge medical advancements are accessible to the community it serves.

Locations

Tunis, , Tunisia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported