Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

December 21, 2021 updated by: Hyun-Jung Shin, Seoul National University Hospital

Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia

Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Patients who are taking other serotonin receptor antagonists
  • Patients who have galactose intolerance or Lapp lactase deficiency
  • patients who have glucose-galactose malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Ramosetron-ODT
Drug: Ramosetron
Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in the occurrence of postoperative nausea
Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative vomiting
Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the severity of postoperative nausea
Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change of patient's satisfaction score
Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the number of postoperative administration of rescue antiemetic drug
Time Frame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hyun-Jung Shin, MD., PhD., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2002/594-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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