Effect of Ramosetron on Post-discharge Nausea and Vomiting

NCT ID: NCT03409835

Last Updated: 2018-04-20

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-30

Brief Summary

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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 or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron 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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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ramosetron

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

Ramosetron 0.3 mg is administered after induction of general anesthesia.

Control

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline 2 ml is administered after induction of general anesthesia.

Interventions

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Ramosetron

Ramosetron 0.3 mg is administered after induction of general anesthesia.

Intervention Type DRUG

Normal saline

Normal saline 2 ml is administered after induction of general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

Exclusion Criteria

* American Society of Anesthesiologists physical statue 3 or more
* Planned admission after surgery
* Intravenous anesthesia
* During chemotherapy
* Pregnancy or breastfeeding
* Abnormal liver or kidney function
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyo-Seok Na

Role: CONTACT

1087012913

Facility Contacts

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Hyo-Seok Na

Role: primary

1087012913

Other Identifiers

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PDNV

Identifier Type: -

Identifier Source: org_study_id

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