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Clinical Trials/NCT06431568
NCT06431568
Completed
Not Applicable

Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)

Assiut University1 site in 1 country400 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Assiut University
Enrollment
400
Locations
1
Primary Endpoint
Blood Pressure
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
May 1, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdelrady S Ibrahim, MD

Professor of Anesthesia and ICU

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Pregnant patients undergoing elective caesarean section

Exclusion Criteria

  • Preeclampsia
  • Eclampsia
  • Hypertension

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: one hour

incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron

Secondary Outcomes

  • Heart rate(One hour)
  • Vasopressor(One hour)

Study Sites (1)

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