Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

Uterine Myoma, Ovary Neoplasm, Adenomyosis Clinical Trial

— PONV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02011659
• Other study ID #: PONV-NHIS-GYN-001
• Status: Recruiting
• Phase: Phase 3
• First received: December 10, 2013
• Last updated: December 12, 2013
• Start date: November 2013

Study information

• Verified date: December 2013
• Source: National Health Insurance Service Ilsan Hospital
• Contact: San-Hui Lee, M.D.
• Phone: +82-900-0218
• Email: sanaram[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Ovarian Neoplasms
• Uterine Myoma, Ovary Neoplasm, Adenomyosis
• Vomiting

Intervention

Drug:
• Ramosetron

Locations

Country	Name	City	State
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang-si

Sponsors (1)

Lead Sponsor	Collaborator
National Health Insurance Service Ilsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence or intensity of PONV		during postoperative hospital stays (2 days)	No
Secondary	Adverse reaction associated with Ramosetron injection		Postoperatvie 7 days (at OPD based)	Yes