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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ramosetron 0.3

Drug

The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.

ramosetron 0.45

Drug

The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.

ramosetron 0.6

Drug

The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.

Primary outcomes

postoperative nausea and vomiting

Time frame: within 48h after surgery

incidence of nausea and vomiting during the first 48 h after surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 23, 2015
Registry last updated: Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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