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Effect of Ramosetron on Bowel Motility After Colorectal Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Kyunghee University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mi Kyeong Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01427127
First received: August 25, 2011
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: Ramosetron
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • time from surgery to passage of gas [ Time Frame: within 10days after surgery ] [ Designated as safety issue: No ]
  • time from surgery to defecation [ Time Frame: within 10 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence and severity of postoperative nausea and vomiting [ Time Frame: 0 - 6 hours, 6-24 hours, and 24-48 hours after surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 64
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427127

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

Locations
Korea, Republic of
School of Medicine, Kyung Hee University Recruiting
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Mi Kyeong Kim School of Medicine, Kyung Hee University
  More Information

No publications provided

Responsible Party: Mi Kyeong Kim, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01427127     History of Changes
Other Study ID Numbers: RAMS
Study First Received: August 25, 2011
Last Updated: August 30, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Nausea
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Vomiting
Ramosetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014