Effect of Ramosetron on Bowel Motility After Colorectal Resection

Kyung Hee University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01427127

RAMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

ramosetron

Experimental group

Description:

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

Treatment:

Drug: Ramosetron

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Ramosetron