Ondansetron Prior Spinal Anaesthesia

Completed

• Conditions: Cesarean Section

• Registration Number: NCT06431568
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-03-02
• Status Verified: 2024-05
• Study Completion: 2024-05-01
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant patients undergoing elective caesarean section

Exclusion Criteria

• Preeclampsia
• Eclampsia
• Hypertension
• Diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Pressure	one hour	incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron

Secondary Outcome Measures

Name	Time	Method
Heart rate	One hour	Incidence of bradycardia after ondansetron
Vasopressor	One hour	Incidence of use of ephedrine or phenylpherine

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt