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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02011659
Recruitment Status : Unknown
Verified December 2013 by San-Hui Lee, National Health Insurance Service Ilsan Hospital.
Recruitment status was:  Recruiting
First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment Phase
Uterine Myoma, Ovary Neoplasm, Adenomyosis Drug: Ramosetron Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ramosetron Drug: Ramosetron

Outcome Measures

Primary Outcome Measures :
  1. Incidence or intensity of PONV [ Time Frame: during postoperative hospital stays (2 days) ]

Secondary Outcome Measures :
  1. Adverse reaction associated with Ramosetron injection [ Time Frame: Postoperatvie 7 days (at OPD based) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT02011659

Contact: San-Hui Lee, M.D. +82-900-0218 sanaram@naver.com

Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Goyang-si, Korea, Republic of, 410-719
Principal Investigator: San-Hui Lee, M.D.         
Sponsors and Collaborators
National Health Insurance Service Ilsan Hospital
More Information

Responsible Party: San-Hui Lee, Clinical assistant professor, National Health Insurance Service Ilsan Hospital
ClinicalTrials.gov Identifier: NCT02011659     History of Changes
Other Study ID Numbers: PONV-NHIS-GYN-001
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by San-Hui Lee, National Health Insurance Service Ilsan Hospital:
Ramosetron, postoperative nausea and vomiting, laparoscopy

Additional relevant MeSH terms:
Ovarian Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents