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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by San-Hui Lee, National Health Insurance Service Ilsan Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011659
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
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.
Information provided by (Responsible Party):
San-Hui Lee, National Health Insurance Service Ilsan Hospital
  Purpose

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 Intervention Phase
Uterine Myoma, Ovary Neoplasm, Adenomyosis Drug: Ramosetron Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by San-Hui Lee, National Health Insurance Service Ilsan Hospital:

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

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

Estimated Enrollment: 128
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ramosetron Drug: Ramosetron

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

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
Criteria

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


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

Locations
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 Submitted: December 10, 2013
First Posted: December 13, 2013
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:
Adenomyosis
Nausea
Vomiting
Leiomyoma
Myofibroma
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
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
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents