Effect of Ramosetron on Bowel Motility After Colorectal Resection
1 other identifier
interventional
64
1 country
1
Brief Summary
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2010
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
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 1, 2011
August 1, 2011
1 year
August 25, 2011
August 30, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
time from surgery to passage of gas
within 10days after surgery
time from surgery to defecation
within 10 days after surgery
Secondary Outcomes (1)
incidence and severity of postoperative nausea and vomiting
0 - 6 hours, 6-24 hours, and 24-48 hours after surgery
Study Arms (2)
ramosetron
EXPERIMENTALPatients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.
Normal saline
PLACEBO COMPARATORPatients received intravenous normal saline at end of surgery and 24hr after surgery.
Interventions
Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.
Eligibility Criteria
You may qualify if:
- yr of age,
- ASA I or II,
- scheduled for laparoscopic colorectal surgery
You may not qualify if:
- antiemetic use within 24hr prior to surgery
- steroid use within 24hr prior to surgery or 48hr after surgery
- insulin dependent DM
- cardiovascular or pulmonary disease
- renal or hepatic insufficiency
- BMI \>=35kg/m2
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Medicine, Kyung Hee University
Seoul, 130-702, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mi Kyeong Kim
School of Medicine, Kyung Hee University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 25, 2011
First Posted
September 1, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 1, 2011
Record last verified: 2011-08