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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: ramosetron 0.3; Drug: ramosetron 0.6; Drug: ramosetron 0.45

Study type: Interventional

Funder types: Other

Identifiers

NCT02478645

4-2014-1065

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 3 patient groups

ramosetron 0.3

Experimental group

Treatment:

Drug: ramosetron 0.3

ramosetron 0.45

Active Comparator group

Treatment:

Drug: ramosetron 0.45

ramosetron 0.6

Active Comparator group

Treatment:

Drug: ramosetron 0.6