Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting
Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting
1 other identifier
interventional
132
1 country
1
Brief Summary
The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic 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 Mar 2012
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
First Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 23, 2012
March 1, 2012
4 months
November 28, 2011
March 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of postoperative nausea and vomiting
24 hours after surgery
Secondary Outcomes (1)
severity of nausea
for 24 hours after sugery
Study Arms (2)
continuous infusion
ACTIVE COMPARATORcontinuous infusion of palonosetron added to prophylactic single injection of palonosetron
singel injection
PLACEBO COMPARATORcontinuous infusion of normal saline added to prophylactic single injection of palonosetron
Interventions
continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
continuous infusion of normal saline after single injection of palonosetron 0.075mg
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
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- Clnical professor
Study Record Dates
First Submitted
November 28, 2011
First Posted
November 30, 2011
Study Start
March 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
March 23, 2012
Record last verified: 2012-03