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Effect of Ramosetron on Bowel Motility After Colorectal Resection

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ClinicalTrials.gov Identifier: NCT01427127
Recruitment Status : Unknown
Verified August 2011 by Mi Kyeong Kim, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
Sponsor:
Information provided by (Responsible Party):
Mi Kyeong Kim, Kyunghee University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Ramosetron Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection
Study Start Date : December 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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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 Name: 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 Name: nasea (Astellas Pharma Korea, Inc.)


Outcome Measures
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Primary Outcome Measures :
  1. time from surgery to passage of gas [ Time Frame: within 10days after surgery ]
  2. time from surgery to defecation [ Time Frame: within 10 days after surgery ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427127


Contacts
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Contact: Mi Kyeong Kim, Professor 82-2-958-8604 ext 92-2-958-8114 mkanes@gmail.com

Locations
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Korea, Republic of
School of Medicine, Kyung Hee University Recruiting
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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Principal Investigator: Mi Kyeong Kim School of Medicine, Kyung Hee University
More Information
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Responsible Party: Mi Kyeong Kim, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01427127    
Other Study ID Numbers: RAMS
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: September 1, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Ramosetron
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action