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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)

Primary Purpose

Caesarean Section, Spinal Anesthesia

Status
Not yet recruiting
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Ondansetron 8mg
Dexamethasone 8mg
Normal saline
Sponsored by
Muhammad Mubariz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caesarean Section

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Akhtar Saeed Trust Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ondansetron

Dexamethasone

Placebo

Arm Description

Patients given Ondansetron (8mg)

Patients given Dexamethasone (8mg)

Outcomes

Primary Outcome Measures

Intraoperative nausea
Measured by an 11-point numeric rating scale
Intraoperative vomiting
Number of episodes of vomiting throughout the procedure

Secondary Outcome Measures

Intraoperative pain
Measured by an 11-point numeric rating scale

Full Information

First Posted
October 13, 2022
Last Updated
October 15, 2022
Sponsor
Muhammad Mubariz
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1. Study Identification

Unique Protocol Identification Number
NCT05583214
Brief Title
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
Acronym
ODP
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Mubariz

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Section, Spinal Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Patients given Ondansetron (8mg)
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patients given Dexamethasone (8mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8mg
Intervention Description
8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8mg
Intervention Description
8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline will be given IV stat to the group after induction of spinal anesthesia
Primary Outcome Measure Information:
Title
Intraoperative nausea
Description
Measured by an 11-point numeric rating scale
Time Frame
20 minutes after initiation of procedure
Title
Intraoperative vomiting
Description
Number of episodes of vomiting throughout the procedure
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Intraoperative pain
Description
Measured by an 11-point numeric rating scale
Time Frame
20 minutes after the initiation of procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Mubariz, MBBS
Phone
+923364241055
Email
mubariz1997@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Mubariz, MBBS
Organizational Affiliation
House Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akhtar Saeed Trust Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53710
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raheel
Phone
+92 3211415063
Email
principal@amdc.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Mubariz, MBBS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient's consent form, MR number Detailed rating scale data Intraoperative blood pressure and heart rate data

Learn more about this trial

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

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