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

National Health Insurance Service Ilsan Hospital

Status and phase: Unknown; Phase 3

Conditions: Uterine Myoma, Ovary Neoplasm, Adenomyosis

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT02011659

PONV-NHIS-GYN-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 128 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 1 patient group

Ramosetron

Active Comparator group

Treatment:

Drug: Ramosetron