NCT02478645

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	ramosetron 0.3	The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
DRUG	ramosetron 0.45	The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
DRUG	ramosetron 0.6	The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.

Timeline

• Start date: 2015-06-19
• Primary completion: 2016-02-06
• Completion: 2016-02-06
• First posted: 2015-06-23
• Last updated: 2017-01-25

Locations

1 site across 1 country: South Korea