Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section
Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section
1 other identifier
interventional
160
0 countries
N/A
Brief Summary
Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
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
First Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 30, 2019
March 1, 2019
1.2 years
March 26, 2019
April 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
Nausea and vomiting were recorded as present or absent, All measurements and ratings were completed at the time when patients rated their PONV intensity. We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.
Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention
Secondary Outcomes (1)
Change in postoperative pain (assessed by VAS ).
Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours
Study Arms (2)
Dexamethasone
ACTIVE COMPARATORCyclizine
ACTIVE COMPARATORInterventions
The first group (Dexamethasone) will receive 8 mg IV dexamethasone within 1-2 minutes after the umbilical cord is clamped. The second group (Cyclizine) will receive 50 mg cyclizine within 1-2 minutes after the umbilical cord is clamped
Eligibility Criteria
You may qualify if:
- Female
- to 45 years old
- Parturient
- ASA I-II
- Full Term
You may not qualify if:
- Women who has obstetric complications.
- Women with evidence of foetal compromise.
- Patients who have gastro-intestinal diseases.
- Administration of anti-emetic drugs within 24 hours before operation.
- Patients who have hyperemesis gravidarium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2019
First Posted
April 30, 2019
Study Start
September 1, 2019
Primary Completion
October 31, 2020
Study Completion
December 1, 2020
Last Updated
April 30, 2019
Record last verified: 2019-03