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

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: ramosetron 0.6; Drug: ramosetron 0.3; Drug: ramosetron 0.45

• Registration Number: NCT02478645
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-18
• Study Start: 2015-06-19
• Study First Posted: 2015-06-23
• Primary Completion: 2016-02-06
• Study Completion: 2016-02-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
• patient scheduled for elective gynecological laparoscopic surgery.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramosetron 0.6	ramosetron 0.6	-
ramosetron 0.3	ramosetron 0.3	-
ramosetron 0.45	ramosetron 0.45	-

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	within 48h after surgery	incidence of nausea and vomiting during the first 48 h after surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu; 🇰🇷 Seoul, Korea, Republic of