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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Ramosetron Drug: Normal saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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Arms and Interventions
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Arm Intervention/treatment
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)
 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
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Time from surgery to the passage of first flatus [ Time Frame: Within 10 days after surgery ]

Secondary Outcome Measures :
  1. Time to first defecation [ Time Frame: Within 10 days after surgery ]
  2. Incidence of postoperative ileus [ Time Frame: Within 10 days after surgery ]

Other Outcome Measures:
  1. Incidence and severity of postoperative nausea [ Time Frame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery ]
  2. Incidence and severity of postoperative vomiting [ Time Frame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849483


Contacts
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Contact: Youngsoon Kim, M.D., Ph.D. +82-958-8589 ys.kim@khu.ac.kr

Locations
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Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Contact: Youngsoon Kim    958-8589    ys.kim@khu.ac.kr   
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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Principal Investigator: Mi Kyeong Kim, M.D., Ph.D. Kyunghee University Medical Center
More Information
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Responsible Party: Mi Kyeong Kim, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02849483    
Other Study ID Numbers: KHUH 2016-05-201
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mi Kyeong Kim, Kyunghee University Medical Center:
PONV
digestive signs and symptoms
vomiting
 antiemetics
nausea
ramosetron
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Ramosetron
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action