Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)
1 other identifier
interventional
100
1 country
1
Brief Summary
A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV). Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.
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 Sep 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
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 21, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedNovember 23, 2011
November 1, 2011
2 months
November 21, 2011
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative nausea and vomiting
For 24 hours after surgery
Secondary Outcomes (1)
Severity of nausea
For 24 hours after surgery
Study Arms (2)
Tiva group (Group T)
PLACEBO COMPARATORTIVA plus palonosetron group (Group T+P)
ACTIVE COMPARATORInterventions
Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia
Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia
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
- Clnical professor
Study Record Dates
First Submitted
November 21, 2011
First Posted
November 23, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 23, 2011
Record last verified: 2011-11