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Effect of Ramosetron on Bowel Motility After Gynecological Surgery

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

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Time from surgery to the passage of first flatus [ Time Frame: Within 10 days after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Effect of Ramosetron on Bowel Motility After Gynecological Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849483
Other Study ID Numbers  ICMJE KHUH 2016-05-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mi Kyeong Kim, Kyunghee University Medical Center
Study Sponsor  ICMJE Kyunghee University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mi Kyeong Kim, M.D., Ph.D. Kyunghee University Medical Center
PRS Account Kyunghee University Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP