Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

NCT ID: NCT05583214

Last Updated: 2022-10-18

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-01-31

Brief Summary

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The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:

Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.

Which drug is the best at reducing intraoperative pain.

Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.

A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.

Data collected from the three groups will be analyzed using SPSS software.

Detailed Description

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Conditions

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Caesarean Section Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ondansetron

Patients given Ondansetron (8mg)

Group Type EXPERIMENTAL

Ondansetron 8mg

Intervention Type DRUG

8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia

Dexamethasone

Patients given Dexamethasone (8mg)

Group Type EXPERIMENTAL

Dexamethasone 8mg

Intervention Type DRUG

8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia

Placebo

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline will be given IV stat to the group after induction of spinal anesthesia

Interventions

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Ondansetron 8mg

8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia

Intervention Type DRUG

Dexamethasone 8mg

8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia

Intervention Type DRUG

Normal saline

Normal saline will be given IV stat to the group after induction of spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age above 20 but less than 35 years old
* Given informed consent
* No contraindication to spinal anesthesia
* ASA I or II

Exclusion Criteria

* Age less than 20 or more than 35 years old
* Non-consenting
* Contraindication to spinal anesthesia
* ASA III or IV
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Muhammad Mubariz

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Mubariz

House Officer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muhammad Mubariz, MBBS

Role: PRINCIPAL_INVESTIGATOR

House Officer

Locations

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Akhtar Saeed Trust Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Muhammad Mubariz, MBBS

Role: CONTACT

+923364241055

Facility Contacts

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Raheel

Role: primary

+92 3211415063

Other Identifiers

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UMO708991

Identifier Type: -

Identifier Source: org_study_id

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