search
Back to results

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

Primary Purpose

Uterine Myoma, Ovary Neoplasm, Adenomyosis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Sponsored by
National Health Insurance Service Ilsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Myoma, Ovary Neoplasm, Adenomyosis focused on measuring Ramosetron, postoperative nausea and vomiting, laparoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Health Insurance Service Ilsan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Ramosetron

Arm Description

Outcomes

Primary Outcome Measures

Incidence or intensity of PONV

Secondary Outcome Measures

Adverse reaction associated with Ramosetron injection

Full Information

First Posted
December 10, 2013
Last Updated
December 12, 2013
Sponsor
National Health Insurance Service Ilsan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02011659
Brief Title
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy
Acronym
PONV
Official Title
A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Insurance Service Ilsan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
Detailed Description
Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma, Ovary Neoplasm, Adenomyosis
Keywords
Ramosetron, postoperative nausea and vomiting, laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Primary Outcome Measure Information:
Title
Incidence or intensity of PONV
Time Frame
during postoperative hospital stays (2 days)
Secondary Outcome Measure Information:
Title
Adverse reaction associated with Ramosetron injection
Time Frame
Postoperatvie 7 days (at OPD based)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
San-Hui Lee, M.D.
Phone
+82-900-0218
Email
sanaram@naver.com
Facility Information:
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang-si
ZIP/Postal Code
410-719
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
San-Hui Lee, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
31538078
Citation
Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.
Results Reference
derived

Learn more about this trial

Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

We'll reach out to this number within 24 hrs