Effect of Ramosetron on Bowel Motility After Gynecological Surgery

• ClinicalTrials.gov Identifier: NCT02849483
• Recruitment Status: Unknown
• First Posted: July 29, 2016
• Last Update Posted: January 12, 2017
• Sponsor: Kyunghee University Medical Center
• Information provided by (Responsible Party): Mi Kyeong Kim, Kyunghee University Medical Center

Tracking Information

• First Submitted Date: July 27, 2016
• First Posted Date: July 29, 2016
• Last Update Posted Date: January 12, 2017
• Study Start Date: July 2016
• Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 28, 2016): Time from surgery to the passage of first flatus [ Time Frame: Within 10 days after surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2016)

• Time to first defecation [ Time Frame: Within 10 days after surgery ]
• Incidence of postoperative ileus [ Time Frame: Within 10 days after surgery ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 28, 2016)

• Incidence and severity of postoperative nausea [ Time Frame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery ]
• Incidence and severity of postoperative vomiting [ Time Frame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effect of Ramosetron on Bowel Motility After Gynecological Surgery
• Official Title: Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Postoperative Nausea and Vomiting

Intervention

• Drug: Ramosetron
  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.
  Other Name: Nasea
• Drug: Normal 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.

Study Arms

• Experimental: Ramosetron
  2 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)
  Intervention: Drug: Ramosetron
• Placebo Comparator: Control
  dexamethasone 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
  Intervention: Drug: Normal saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 28, 2016): 88
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2017
• Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02849483
• Other Study ID Numbers: KHUH 2016-05-201
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Mi Kyeong Kim, Kyunghee University Medical Center
• Study Sponsor: Kyunghee University Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mi Kyeong Kim, M.D., Ph.D.; Kyunghee University Medical Center

• PRS Account: Kyunghee University Medical Center
• Verification Date: January 2017