Effect of Ramosetron on Bowel Motility After Colorectal Resection

Phase 4

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Ramosetron

• Registration Number: NCT01427127
• Lead Sponsor: Kyunghee University Medical Center

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.

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 Timeline

• Study Start: 2010-12
• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-30
• Last Update Submitted: 2011-08-30
• Study First Posted: 2011-09-01
• Last Update Posted: 2011-09-01
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ramosetron	Ramosetron	Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.
Normal saline	Ramosetron	Patients received intravenous normal saline at end of surgery and 24hr after surgery.

Primary Outcome Measures

Name	Time	Method
time from surgery to passage of gas	within 10days after surgery
time from surgery to defecation	within 10 days after surgery

Secondary Outcome Measures

Name	Time	Method
incidence and severity of postoperative nausea and vomiting	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

Trial Locations

Locations (1)

School of Medicine, Kyung Hee University; 🇰🇷 Seoul, Korea, Republic of