Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
1 other identifier
interventional
88
0 countries
N/A
Brief Summary
The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
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 Jul 2014
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
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
April 1, 2017
10 months
October 31, 2015
March 8, 2017
April 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting during 24 hours postoperatively
24 hours
Study Arms (2)
aprepitant plus palonosetron
EXPERIMENTALaprepitant 80 mg palonosetron 0.075 mg
aprepitant plus ramosetron
ACTIVE COMPARATORaprepitant 80 mg ramosetron 0.3 mg
Interventions
aprepitant 80 mg is given to all patients before surgery
palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
Eligibility Criteria
You may qualify if:
- Non smoking, female patients, scheduled for laparoscopic cholecystectomy
You may not qualify if:
- Patients with gastrointestinal disorder,
- Patients with allergies to any study medication,
- Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Younghoon Jeon
- Organization
- Kyungpook National University
Publication Agreements
- PI is Sponsor Employee
- Yes
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
- Professor
Study Record Dates
First Submitted
October 31, 2015
First Posted
November 5, 2015
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share