Ramosetron Pre-treatment for PONV and QT Prolongation | NCT03278522

Studies
Ramosetron Pre-treatment for PONV and QT Prolongation

NCT03278522

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Mar 9, 2018Actual

Enrollment

64Actual

Phase

Phase 4

Conditions

PONV
Prolonged QTc Interval

Interventions

Ramosetron

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Sep 6, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2018

Last Update Posted Date

Mar 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ka Young Rhee, Associate Professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug	Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery	ramosetron iv at induction (I) ramosetron iv at recovery (R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QTc interval change	Difference of QTc interval from preoperative value	within 10 min after arrival at PACU, and 24 hour after discharge from PACU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent laparoscopic gynecologic surgery

Exclusion Criteria:

preoperative bradyarrhythmia in ECG

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ka Young Rhee, MD,PhD	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lee Sung Ho		Seoul		05030	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C071315	ramosetron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided