Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Ramosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01806948

SNUBH_GO_017

Details and patient eligibility

About

We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Enrollment: 96 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laparoscopy for benign gynecologic disease

Exclusion criteria

• Vomiting within 24 hours before surgery
• Not using patient controlled analgesics postoperatively

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.

Treatment:

Drug: Ramosetron

Experimental

Experimental group

Description:

Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.

Treatment:

Drug: Ramosetron