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Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Phase 4
Conditions
Postoperative Nausea and Vomiting
Interventions
Drug: Normal saline
Drug: Ramosetron
Registration Number
NCT02849483
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 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
88
Inclusion Criteria
  • 20-70 yrs of age
  • ASA(American Society of Anesthesiologists) physical status class I or II
  • Scheduled for gynecological laparoscopic surgery
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlNormal salinedexamethasone 10 mg iv before induction, 2 ml of normal saline iv at the end of surgery, 4 ml of normal saline added to the iv PCA
RamosetronRamosetron2 ml of normal saline iv before induction, ramosetron 0.3 mg iv at the end of surgery, ramosetron 0.6 mg added to the iv PCA(Patient-Controlled Analgesia)
Primary Outcome Measures
NameTimeMethod
Time from surgery to the passage of first flatusWithin 10 days after surgery
Secondary Outcome Measures
NameTimeMethod
Incidence of postoperative ileusWithin 10 days after surgery
Time to first defecationWithin 10 days after surgery

Trial Locations

Locations (1)

Kyung Hee University Hospital

🇰🇷

Seoul, Korea, Republic of

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