Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444737
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-13
Brief Title:
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
Sponsor:
Mongi Slim Hospital
Organization:
Mongi Slim Hospital
Study Overview
Official Title:
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPDPH
Brief 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 010 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
Group O ondansetron receiving Intravenous IV ondansetron 010 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
Detailed Description:
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections However it is not denied from complications
Post-dural puncture headache is a major complication of spinal anesthesia with an incidence ranging from 15 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 010 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
Post-dural puncture headache is a major complication of spinal anesthesia with an incidence ranging from 15 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 010 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None