Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
NCT ID: NCT06444737
Last Updated: 2024-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-11-30
2024-08-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group O
Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Intravenous ondansetron
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Group C
Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
Intravenous normal saline
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Interventions
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Intravenous ondansetron
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Intravenous normal saline
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Mongi Slim Hospital
OTHER
Responsible Party
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Mhamed Sami Mebazaa
Professor head of anesthesiology and ICU department
Locations
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Mongi slim hospital
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ondansetron effect on PDPH
Identifier Type: -
Identifier Source: org_study_id
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