Ondansetron Prior Spinal Anaesthesia

NCT ID: NCT06431568

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pregnant patients undergoing elective caesarean section

Exclusion Criteria

* Preeclampsia
* Eclampsia
* Hypertension
* Diabetes
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kuwait Institute for Medical Specialization

OTHER_GOV

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrady S Ibrahim, MD

Professor of Anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelrady S Ibrahim, .M.D.

Role: PRINCIPAL_INVESTIGATOR

Assiut University Faculty Of Medicine

Locations

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Assiut university faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 30881108 (View on PubMed)

Other Identifiers

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Kuwait MOH

Identifier Type: OTHER

Identifier Source: secondary_id

IRB0000871252

Identifier Type: -

Identifier Source: org_study_id

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