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NCT02478645 Clinical Trial

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

Postoperative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02478645
Other study ID # 4-2014-1065
Secondary ID
Status Completed
Phase Phase 4
First received June 18, 2015
Last updated January 24, 2017
Start date June 19, 2015
Est. completion date February 6, 2016

Study information
Verified date January 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date February 6, 2016
Est. primary completion date February 6, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- patient between 20 and 70 of age with ASA physical status ?-?

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ramosetron 0.3
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
• ramosetron 0.45
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
• ramosetron 0.6
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative nausea and vomiting incidence of nausea and vomiting during the first 48 h after surgery within 48h after surgery
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