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 (ODP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caesarean Section; Spinal Anesthesia
• Intervention / Treatment: Drug: Ondansetron 8mg; Drug: Dexamethasone 8mg; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Muhammad Mubariz, MBBS; Phone Number: +923364241055; Email: mubariz1997@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 53710
      • Akhtar Saeed Trust Hospital
      • Contact: Raheel; Phone Number: +92 3211415063; Email: principal@amdc.edu.pk
      • Principal Investigator: Muhammad Mubariz, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Normal saline; Normal saline will be given IV stat to the group after induction of spinal anesthesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pain	Measured by an 11-point numeric rating scale	20 minutes after the initiation of procedure

Collaborators and Investigators

• Sponsor: Muhammad Mubariz
• Investigators: Principal Investigator: Muhammad Mubariz, MBBS, House Officer

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Dexamethasone; Ondansetron
• Other Study ID Numbers: UMO708991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient's consent form, MR number Detailed rating scale data Intraoperative blood pressure and heart rate data
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No