Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

Phase 3UnknownNCT02011659

National Health Insurance Service Ilsan Hospital128 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

Uterine Myoma, Ovary Neoplasm, Adenomyosis

Interventions

RamosetronDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National Health Insurance Service Ilsan Hospital

Goyang-si, South Korea

RECRUITING

Outcomes

Primary Outcomes

Incidence or intensity of PONV

Time frame: during postoperative hospital stays (2 days)

Secondary Outcomes

Adverse reaction associated with Ramosetron injection

Time frame: Postoperatvie 7 days (at OPD based)

Central Contacts

San-Hui Lee, M.D.

CONTACT

+82-900-0218 sanaram@naver.com

Data from ClinicalTrials.gov

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