Ondansetron Prior Spinal Anaesthesia

Cesarean Section Clinical Trial

— Ondansetron  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06431568
• Other study ID #: IRB0000871252
• Secondary ID: Kuwait MOH
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 1, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant patients undergoing elective caesarean section

Exclusion Criteria:

• Preeclampsia

• Eclampsia

• Hypertension

• Diabetes

Related Conditions & MeSH terms

• Cesarean Section

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Kuwait Institute for Medical Specialization

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron	one hour
Secondary	Heart rate	Incidence of bradycardia after ondansetron	One hour
Secondary	Vasopressor	Incidence of use of ephedrine or phenylpherine	One hour