Effect of Ramosetron on Bowel Motility After Colorectal Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Ramosetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron<br>Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery. | Drug: Ramosetron<br>* Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.<br>* Other names: nasea (Astellas Pharma Korea, Inc.);|
| Placebo Comparator: Normal saline<br>Patients received intravenous normal saline at end of surgery and 24hr after surgery. | Drug: Ramosetron<br>* Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.<br>* Other names: nasea (Astellas Pharma Korea, Inc.);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from surgery to passage of gas |  | within 10days after surgery | 
| time from surgery to defecation |  | within 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 - 6 hours, 6-24 hours, and 24-48 hours after surgery |