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](https://trials-media.s3.amazonaws.com/orgs/muhammad-mubariz.jpeg)
About this trial
This is an interventional prevention trial for Caesarean Section
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
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
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
We'll reach out to this number within 24 hrs