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Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Primary Purpose

Day Surgery

Status

Recruiting

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramosetron

About this trial

This is an interventional prevention trial for Day Surgery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ramosetron-ODT

Control

Arm Description

Outcomes

Primary Outcome Measures

The change in the occurrence of postoperative nausea

The change in the occurrence of postoperative vomiting

Secondary Outcome Measures

The change in the severity of postoperative nausea

Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)

The change of patient's satisfaction score

Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)

The change in the number of postoperative administration of rescue antiemetic drug

Full Information

NCT ID

NCT04297293

First Posted

March 2, 2020

Last Updated

December 21, 2021

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04297293

Brief Title

Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

February 28, 2022 (Anticipated)

Study Completion Date

February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Day Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Non-Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ramosetron-ODT

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Ramosetron

Intervention Description

Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)

Primary Outcome Measure Information:

Title

The change in the occurrence of postoperative nausea

Time Frame

Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Title

The change in the occurrence of postoperative vomiting

Time Frame

Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Secondary Outcome Measure Information:

Title

The change in the severity of postoperative nausea

Description

Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)

Time Frame

Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Title

The change of patient's satisfaction score

Description

Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)

Time Frame

Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

Title

The change in the number of postoperative administration of rescue antiemetic drug

Time Frame

Postoperative 30 minute, 3 hour, 24 hour, and 48 hour

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun-Jung Shin, MD., PhD.

Phone

82317877499

hjshin.anesth@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun-Jung Shin, MD., PhD.

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun-Jung Shin, Ph.D., M.D.

Phone

82317877499

hjshin.anesth@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

35546414

Citation

Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.

Results Reference

derived

Learn more about this trial

Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

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