Effect of Ramosetron on Bowel Motility After Colorectal Resection

August 30, 2011 updated by: Mi Kyeong Kim, Kyunghee University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mi Kyeong Kim, Professor
  • Phone Number: 92-2-958-8114 82-2-958-8604
  • Email: mkanes@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 130-702
        • Recruiting
        • School of Medicine, Kyung Hee University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence and severity of postoperative nausea and vomiting
Time Frame: 0 - 6 hours, 6-24 hours, and 24-48 hours after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Mi Kyeong Kim, School of Medicine, Kyung Hee University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

September 1, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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