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Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02849483
Enrollment
88
Registered
2016-07-29
Start date
2016-07-31
Completion date
2017-07-31
Last updated
2017-01-12

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

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV, digestive signs and symptoms, vomiting, antiemetics, nausea, ramosetron

Brief summary

Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment of irritable bowel syndrome. The investigators examine the effect of ramosetron on postoperative bowel motility.

Detailed description

Ramosetron, a new potent and long-acting selective 5-HT3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of diarrhea-predominant 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

Administer 2 ml of normal saline iv before induction. Inject ramosetron 0.3 mg iv at the end of surgery. Add ramosetron 0.6 mg to the iv PCA.

DRUGNormal saline

Administer dexamethasone 10 mg iv before induction. Inject 2 ml of normal saline iv at the end of surgery. Add 4 ml of normal saline to the iv PCA.

Sponsors

Kyunghee University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* 20-70 yrs of age * ASA(American Society of Anesthesiologists) physical status class I or II * Scheduled for gynecological laparoscopic surgery

Exclusion criteria

* Allergic to study drugs * Antiemetics or steroids use within 24 hrs prior to surgery * Dependence upon opioids * Insulin dependent Diabetes Mellitus * Cardiovascular or pulmonary disease * Renal or hepatic insufficiency * BMI\>=35kg/m2 * History of motion sickness or PONV * Cigarette smoker * Conversion to open laparotomy from laparoscopic surgery * Pregnants

Design outcomes

Primary

MeasureTime frame
Time from surgery to the passage of first flatusWithin 10 days after surgery

Secondary

MeasureTime frame
Time to first defecationWithin 10 days after surgery
Incidence of postoperative ileusWithin 10 days after surgery

Other

MeasureTime frame
Incidence and severity of postoperative nausea0-6 hours, 6-24 hours, and 24-48 hours after surgery
Incidence and severity of postoperative vomiting0-6 hours, 6-24 hours, and 24-48 hours after surgery

Countries

South Korea

Contacts

Primary ContactYoungsoon Kim, M.D., Ph.D.
ys.kim@khu.ac.kr+82-958-8589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026