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

Phase 4

Not yet recruiting

• Conditions: Spinal Anesthesia; Caesarean Section
• Interventions: Drug: Ondansetron 8mg; Drug: Dexamethasone 8mg; Drug: Normal saline

• Registration Number: NCT05583214
• Lead Sponsor: Muhammad Mubariz

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-15
• Study First Posted: 2022-10-17
• Last Update Posted: 2022-10-18
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron 8mg	Patients given Ondansetron (8mg)
Dexamethasone	Dexamethasone 8mg	Patients given Dexamethasone (8mg)
Placebo	Normal saline	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intraoperative pain	20 minutes after the initiation of procedure	Measured by an 11-point numeric rating scale

Trial Locations

Locations (1)

Akhtar Saeed Trust Hospital; 🇵🇰 Lahore, Punjab, Pakistan