Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

Phase 3

• Conditions: Uterine Myoma, Ovary Neoplasm, Adenomyosis
• Interventions: Drug: Ramosetron

• Registration Number: NCT02011659
• Lead Sponsor: National Health Insurance Service Ilsan Hospital

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

Study Timeline

• Study Start: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13
• Primary Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramosetron	Ramosetron	-

Primary Outcome Measures

Name	Time	Method
Incidence or intensity of PONV	during postoperative hospital stays (2 days)

Secondary Outcome Measures

Name	Time	Method
Adverse reaction associated with Ramosetron injection	Postoperatvie 7 days (at OPD based)

Trial Locations

Locations (1)

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang-si, Korea, Republic of