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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.
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 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:
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group O | Experimental | Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia |
|
| Group C | Placebo Comparator | Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ondansetron | Drug | Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-dural punction headache (PDPH) during the first seven postoperative days. | the occurrence of positional headaches at any time postoperatively | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| day of PDPH's occurence | on postoperatively | 7 days |
| day of PDPH's resolution | on postoperatively | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
parturients scheduled for elective caesarean delivery under spinal anaesthesia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mhamed Sami Mebazaa, professor | Contact | 22252589 | 00216 | msmebazaa@gmail.com |
| Amani Ben Haj Youssef, assistant | Contact | 96874336 | 00216 | amanibhy@hotmail.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mongi slim hospital | Recruiting | Tunis | 2085 | Tunisia |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Intravenous normal saline | Drug | Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia |
|
|
| Headache severity | assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain). | 7 days |
| Need for analgesic treatment due to headaches | paracetamol or NSAIDs | 7 days |
| Occurrence of post-operative nausea and/or vomiting | need of treatement | 7 days |
| Mean arterial pressure in mmgh | Mean arterial pressure during hospitalization | 3 days |
| heart rate | Mean arterial pressure during hospitalization | 3 days |
| D009422 | Nervous System Diseases |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |