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

NCT05583214 | Unknown Phase 4

• 1 other identifier: UMO708991
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Caesarean Section; Spinal Anesthesia

Outcome Measures

Primary Outcomes (2)

• Intraoperative nausea

  Measured by an 11-point numeric rating scale

  20 minutes after initiation of procedure

• Intraoperative vomiting

  Number of episodes of vomiting throughout the procedure

  1 hour

Secondary Outcomes (1)

• Intraoperative pain

  20 minutes after the initiation of procedure

Study Arms (3)

Ondansetron

EXPERIMENTAL

Patients given Ondansetron (8mg)

Drug: Ondansetron 8mg

Dexamethasone

EXPERIMENTAL

Patients given Dexamethasone (8mg)

Drug: Dexamethasone 8mg

Placebo

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Ondansetron 8mg DRUG

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

Ondansetron

Dexamethasone 8mg DRUG

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

Dexamethasone

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Mubariz: lead

Study Sites (1)

Akhtar Saeed Trust Hospital

Lahore, Punjab Province, 53710, Pakistan

Location

MeSH Terms

Interventions

Ondansetron; Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Muhammad Mubariz, MBBS

  House Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Mubariz, MBBS

CONTACT

+923364241055; mubariz1997@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: House Officer

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

PA (1)