Ondansetron Prior Spinal Anaesthesia | NCT06431568

Studies
Ondansetron Prior Spinal Anaesthesia

NCT06431568

Sponsor

Assiut University

Status

Completed

Last Update Posted

May 28, 2024Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Cesarean Section

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Kuwait MOH	Other Identifier	Maternity Hospital

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Mar 2, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

May 22, 2024

First Submission Date that Met QC Criteria

May 22, 2024

First Posted Date

May 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2024

Last Update Posted Date

May 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrady S Ibrahim, MD, Professor of Anesthesia and ICU, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Name	Class
Kuwait Institute for Medical Specialization	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia		Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure	incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron	one hour

Secondary Outcomes

Measure	Description	Time Frame
Heart rate	Incidence of bradycardia after ondansetron	One hour
Vasopressor	Incidence of use of ephedrine or phenylpherine	One hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant patients undergoing elective caesarean section

Exclusion Criteria:

Preeclampsia
Eclampsia
Hypertension
Diabetes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdelrady S Ibrahim, .M.D.	Assiut University Faculty Of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university faculty of medicine		Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30881108	Result	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.