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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ramosetron 0.3
ramosetron 0.45
ramosetron 0.6
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Nausea and Vomiting

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ramosetron 0.3

ramosetron 0.45

ramosetron 0.6

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2015
Last Updated
January 24, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02478645
Brief Title
Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 19, 2015 (Actual)
Primary Completion Date
February 6, 2016 (Actual)
Study Completion Date
February 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ramosetron 0.3
Arm Type
Experimental
Arm Title
ramosetron 0.45
Arm Type
Active Comparator
Arm Title
ramosetron 0.6
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ramosetron 0.3
Intervention Description
The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
ramosetron 0.45
Intervention Description
The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
ramosetron 0.6
Intervention Description
The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
Primary Outcome Measure Information:
Title
postoperative nausea and vomiting
Description
incidence of nausea and vomiting during the first 48 h after surgery
Time Frame
within 48h after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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

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