Effect of Ramosetron on Bowel Motility After Gynecological Surgery

January 11, 2017 updated by: Mi Kyeong Kim, Kyunghee University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Youngsoon Kim, M.D., Ph.D.
  • Phone Number: +82-958-8589
  • Email: ys.kim@khu.ac.kr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from surgery to the passage of first flatus
Time Frame: Within 10 days after surgery
Within 10 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first defecation
Time Frame: Within 10 days after surgery
Within 10 days after surgery
Incidence of postoperative ileus
Time Frame: Within 10 days after surgery
Within 10 days after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of postoperative nausea
Time Frame: 0-6 hours, 6-24 hours, and 24-48 hours after surgery
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
0-6 hours, 6-24 hours, and 24-48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHUH 2016-05-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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