Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery

• Status: Completed
• Trial end date: 2016-02-06
• Target enrollment: 0
• Participant gender: All

Summary

Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Ramosetron

Criteria

Inclusion Criteria:

• patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ

• patient scheduled for elective gynecological laparoscopic surgery.

Exclusion Criteria:

• hepatorenal disease

• BMI > 35 kg/m2

• allergy to ramosetron

• gastrointestinal disease

• vomiting within 24h

• administration of antiemetics or opioids within 24h

• QT prolongation (QTc > 440ms)

• pregnant

• problem with communication