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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Health Insurance Service Ilsan Hospital
Sponsor:
Information provided by (Responsible Party):
San-Hui Lee, National Health Insurance Service Ilsan Hospital
ClinicalTrials.gov Identifier:
NCT02011659
First received: December 10, 2013
Last updated: December 12, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 National Health Insurance Service Ilsan Hospital:

Primary Outcome Measures:
  • Incidence or intensity of PONV [ Time Frame: during postoperative hospital stays (2 days) ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 10, 2013
Last Updated: December 12, 2013
Health Authority: Korea: Ministry for Health and Welfare

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

Additional relevant MeSH terms:
Adenomyosis
Leiomyoma
Myofibroma
Ovarian Neoplasms
Vomiting
Adnexal Diseases
Connective Tissue Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Ovarian Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Urogenital Neoplasms
Uterine Diseases
Ramosetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 20, 2014