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Effect of Ramosetron on Bowel Motility After Colorectal Resection

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01427127
Enrollment
64
Registered
2011-09-01
Start date
2010-12-31
Completion date
2011-12-31
Last updated
2011-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGRamosetron

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

Sponsors

Kyunghee University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
time from surgery to passage of gaswithin 10days after surgery
time from surgery to defecationwithin 10 days after surgery

Secondary

MeasureTime frameDescription
incidence and severity of postoperative nausea and vomiting0 - 6 hours, 6-24 hours, and 24-48 hours after surgeryincidence: 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

Countries

South Korea

Contacts

Primary ContactMi Kyeong Kim, Professor
mkanes@gmail.com82-2-958-8604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026