ODP: 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

Sponsor

Muhammad Mubariz (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05583214

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

29.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Caesarean Section Spinal Anesthesia	Drug: Ondansetron 8mg Drug: Dexamethasone 8mg Drug: Normal saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron Patients given Ondansetron (8mg)	Drug: Ondansetron 8mg 8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia
Experimental: Dexamethasone Patients given Dexamethasone (8mg)	Drug: Dexamethasone 8mg 8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia
Placebo Comparator: Placebo	Drug: Normal saline Normal saline will be given IV stat to the group after induction of spinal anesthesia

Arm

Intervention/Treatment

Experimental: Ondansetron

Patients given Ondansetron (8mg)

Drug: Ondansetron 8mg

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

Experimental: Dexamethasone

Patients given Dexamethasone (8mg)

Drug: Dexamethasone 8mg

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

Placebo Comparator: Placebo

Drug: Normal saline

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

Outcome Measures

Primary Outcome Measures

Intraoperative nausea [20 minutes after initiation of procedure]
Measured by an 11-point numeric rating scale
Intraoperative vomiting [1 hour]
Number of episodes of vomiting throughout the procedure

Secondary Outcome Measures

Intraoperative pain [20 minutes after the initiation of procedure]
Measured by an 11-point numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akhtar Saeed Trust Hospital	Lahore	Punjab	Pakistan	53710

Sponsors and Collaborators

Muhammad Mubariz

Investigators

Principal Investigator: Muhammad Mubariz, MBBS, House Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Mubariz, House Officer, Akhtar Saeed Medical and Dental College

ClinicalTrials.gov Identifier:

NCT05583214

Other Study ID Numbers:

UMO708991

First Posted:

Oct 17, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vomiting

Dexamethasone

Ondansetron

Study Results

No Results Posted as of Oct 18, 2022