NCT06431568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 22, 2024

Last Update Submit

May 22, 2024

Conditions

Cesarean Section

Keywords

Spinal anesthesia, Cesarean section, Ondansetron

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

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

    one hour

Secondary Outcomes (2)

  • Heart rate

    One hour

  • Vasopressor

    One hour

Study Arms (1)

Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia

Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants

You may qualify if:

  • Pregnant patients undergoing elective caesarean section

You may not qualify if:

  • Preeclampsia
  • Eclampsia
  • Hypertension
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related 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.

    PMID: 30881108RESULT

Study Officials

  • Abdelrady S Ibrahim, .M.D.

    Assiut University Faculty Of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and ICU

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 28, 2024

Study Start

October 1, 2023

Primary Completion

March 2, 2024

Study Completion

May 1, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

EG(1)