Effect of Ramosetron on Bowel Motility After Colorectal Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ramosetron

Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.

Normal saline

Patients received intravenous normal saline at end of surgery and 24hr after surgery.

Group Type PLACEBO_COMPARATOR

Ramosetron

Intervention Type DRUG

Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.

Interventions

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Ramosetron

Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.

Intervention Type DRUG

Other Intervention Names

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nasea (Astellas Pharma Korea, Inc.)

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No