NCT03278522

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

September 6, 2017

Last Update Submit

March 7, 2018

Conditions

PONVProlonged QTc Interval

Keywords

ramosetron

Outcome Measures

Primary Outcomes (1)

  • QTc interval change

    Difference of QTc interval from preoperative value

    within 10 min after arrival at PACU, and 24 hour after discharge from PACU

Study Arms (2)

ramosetron iv at induction (I)

ACTIVE COMPARATOR

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

Drug: Ramosetron

ramosetron iv at recovery (R)

ACTIVE COMPARATOR

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

Drug: Ramosetron

Interventions

RamosetronDRUG

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

Also known as: ramosetron pre-treatment
ramosetron iv at induction (I)ramosetron iv at recovery (R)

Eligibility Criteria

Age19 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent laparoscopic gynecologic surgery

You may not qualify if:

  • preoperative bradyarrhythmia in ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lee Sung Ho

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Ka Young Rhee, MD,PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

July 1, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

KR(1)