Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting
A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
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
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedNovember 22, 2011
November 1, 2011
3 months
November 15, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative nausea and vomiting for 48 hours after surgery
for 48 hours after surgery
Secondary Outcomes (1)
severity of nausea for 48 hours after surgery
for 48 hours after surgery
Study Arms (2)
Palonosetron
SHAM COMPARATORRamosetron
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- ASA Physical Status 1 or 2
- Elective gynaecological laparoscopic surgery of ≥ 1h duration
You may not qualify if:
- Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
- Vomiting or retching in the 24 h preceding surgery
- Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
- Ongoing vomiting from gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Incheon St. Mary's hospital
Incheon, 403-720, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soo Kyoung Park
Incheon St.Mary's Hospital
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
- Clinical professor
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 22, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 22, 2011
Record last verified: 2011-11