Uterine Myoma, Ovary Neoplasm, Adenomyosis
Conditions
Keywords
Ramosetron, postoperative nausea and vomiting, laparoscopy
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
Interventions
DRUGRamosetron
Sponsors
National Health Insurance Service Ilsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence or intensity of PONV | during postoperative hospital stays (2 days) |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction associated with Ramosetron injection | Postoperatvie 7 days (at OPD based) |
Countries
South Korea
Contacts
Primary ContactSan-Hui Lee, M.D.
Outcome results
None listed