Ramosetron Pre-treatment for PONV and QT Prolongation

NCT ID: NCT03278522

Last Updated: 2018-03-09

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-02-28

Brief Summary

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Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.

Detailed Description

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This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.

Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.

Conditions

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PONV Prolonged QTc Interval

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ramosetron iv at induction (I)

0.6mg of ramosetron is given to the patients intravenously at anesthesia induction

Group Type ACTIVE_COMPARATOR

Ramosetron

Intervention Type DRUG

Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery

ramosetron iv at recovery (R)

0.6mg of ramosetron is given to the patients intravenously at end of surgery

Group Type ACTIVE_COMPARATOR

Ramosetron

Intervention Type DRUG

Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery

Interventions

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Ramosetron

Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery

Intervention Type DRUG

Other Intervention Names

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ramosetron pre-treatment

Eligibility Criteria

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Inclusion Criteria

* patients who underwent laparoscopic gynecologic surgery

Exclusion Criteria

* preoperative bradyarrhythmia in ECG
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ka Young Rhee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Young Rhee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Lee Sung Ho

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUH1160112

Identifier Type: -

Identifier Source: org_study_id

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