Back to resultsEffect of Ramosetron on Bowel Motility After Colorectal Resection
Primary Purpose
Postoperative Nausea and Vomiting
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- 20-70 yr of age,
- ASA I or II,
- scheduled for laparoscopic colorectal surgery
Exclusion Criteria:
- 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
Sites / Locations
- School of Medicine, Kyung Hee UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ramosetron
Normal saline
Arm Description
Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.
Patients received intravenous normal saline at end of surgery and 24hr after surgery.
Outcomes
Primary Outcome Measures
time from surgery to passage of gas
time from surgery to defecation
Secondary Outcome Measures
incidence and severity of postoperative nausea and vomiting
incidence: number of patients who experienced postoperative nausea and vomiting severity: verbal rating scale (VRS, 11 point scale) 0= no nausea to 10 = worst possible nausea
Full Information
NCT ID
NCT01427127
First Posted
August 25, 2011
Last Updated
August 30, 2011
Sponsor
Kyunghee University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01427127
Brief Title
Effect of Ramosetron on Bowel Motility After Colorectal Resection
Official Title
Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Ramosetron, a new potent and long-acting selective 5-HT3 receptor antagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone. There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ramosetron
Arm Type
Experimental
Arm Description
Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Patients received intravenous normal saline at end of surgery and 24hr after surgery.
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
nasea (Astellas Pharma Korea, Inc.)
Intervention Description
Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.
Primary Outcome Measure Information:
Title
time from surgery to passage of gas
Time Frame
within 10days after surgery
Title
time from surgery to defecation
Time Frame
within 10 days after surgery
Secondary Outcome Measure Information:
Title
incidence and severity of postoperative nausea and vomiting
Description
incidence: number of patients who experienced postoperative nausea and vomiting severity: verbal rating scale (VRS, 11 point scale) 0= no nausea to 10 = worst possible nausea
Time Frame
0 - 6 hours, 6-24 hours, and 24-48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-70 yr of age,
ASA I or II,
scheduled for laparoscopic colorectal surgery
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Kyeong Kim, Professor
Phone
82-2-958-8604
Ext
92-2-958-8114
Email
mkanes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Kyeong Kim
Organizational Affiliation
School of Medicine, Kyung Hee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, Kyung Hee University
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Effect of Ramosetron on Bowel Motility After Colorectal Resection
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