Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section
A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section
1 other identifier
interventional
194
1 country
1
Brief Summary
Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus. Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV). Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedNovember 6, 2017
November 1, 2017
1 year
June 3, 2016
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pruritus assessed through questionnaire
24 hours postoperatively
Secondary Outcomes (1)
Post operative nausea and vomiting assessed through questionnaire
24 hours postoperatively
Study Arms (2)
Ondansetron
ACTIVE COMPARATOROndansetron+ dexamethasone
EXPERIMENTALInterventions
Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia
Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia
Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiology physical status 1 and 2
- Scheduled for elective c-section surgery under spinal anesthesia
You may not qualify if:
- Patients with cardiac and psychological problems
- Patients who take sedatives or narcotics
- Patient who have allergy to study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Makassed General Hospital
Beirut, Lebanon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairperson of Anesthesia and Pain Management Department
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 8, 2016
Study Start
June 1, 2016
Primary Completion
June 15, 2017
Study Completion
July 30, 2017
Last Updated
November 6, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share