Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
1 other identifier
interventional
177
1 country
1
Brief Summary
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after 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 phase_4
Started Jun 2015
Shorter than P25 for phase_4
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
June 18, 2015
CompletedStudy Start
First participant enrolled
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2016
CompletedJanuary 25, 2017
January 1, 2017
8 months
June 18, 2015
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative nausea and vomiting
incidence of nausea and vomiting during the first 48 h after surgery
within 48h after surgery
Study Arms (3)
ramosetron 0.3
EXPERIMENTALramosetron 0.45
ACTIVE COMPARATORramosetron 0.6
ACTIVE COMPARATORInterventions
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
Eligibility Criteria
You may qualify if:
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective gynecological laparoscopic surgery.
You may not qualify if:
- hepatorenal disease
- BMI \> 35 kg/m2
- allergy to ramosetron
- gastrointestinal disease
- vomiting within 24h
- administration of antiemetics or opioids within 24h
- QT prolongation (QTc \> 440ms)
- pregnant
- problem with communication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 23, 2015
Study Start
June 19, 2015
Primary Completion
February 6, 2016
Study Completion
February 6, 2016
Last Updated
January 25, 2017
Record last verified: 2017-01