Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-04 @ 1:30 PM
Study NCT ID:
NCT06431568
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ondansetron Prior Spinal Anaesthesia
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)
Status:
COMPLETED
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:
Ondansetron
Brief Summary:
Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.
Detailed Description:
Hypothesis:
Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.
Aim:
Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.
Objectives:
* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.
Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.
Aim:
Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.
Objectives:
* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Kuwait MOH | OTHER | Maternity Hospital | View |