Ramosetron OD Tablet and Postdischarge Nausea and Vomiting

NCT ID: NCT04297293

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Day Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Ramosetron-ODT

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ramosetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Jung Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-Jung Shin, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun-Jung Shin, MD., PhD.

Role: CONTACT

Phone: 82317877499

Email: [email protected]

Facility Contacts

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

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35546414 (View on PubMed)

Other Identifiers

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B-2002/594-003

Identifier Type: -

Identifier Source: org_study_id