Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy (PONV)

December 12, 2013 updated by: San-Hui Lee, National Health Insurance Service Ilsan Hospital

A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy

To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

  • Randomized controlled arm : Placebo versus Ramosetron injection
  • Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 3

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

Study Locations

  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 410-719
        • Recruiting
        • National Health Insurance Service Ilsan Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 18< or =, = or <70 with benign gynecologic disease
  • ASA-Class I-II
  • No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml
  • Non-smoker

Exclusion Criteria:

  • Conversion to laparotomy
  • Hx of malignancy
  • Smoker
  • Suspicious malignancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ramosetron
Drug: Ramosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence or intensity of PONV
Time Frame: during postoperative hospital stays (2 days)
during postoperative hospital stays (2 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse reaction associated with Ramosetron injection
Time Frame: Postoperatvie 7 days (at OPD based)
Postoperatvie 7 days (at OPD based)

Collaborators and Investigators

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

Sponsor

National Health Insurance Service Ilsan Hospital

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

November 1, 2013

Primary Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV-NHIS-GYN-001

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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