Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06444737

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

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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