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Ramosetron Pre-treatment for PONV and QT Prolongation

Primary Purpose

PONV, Prolonged QTc Interval

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ramosetron

About this trial

This is an interventional prevention trial for PONV focused on measuring ramosetron

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

patients who underwent laparoscopic gynecologic surgery

Exclusion Criteria:

preoperative bradyarrhythmia in ECG

Sites / Locations

Lee Sung Ho

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ramosetron iv at induction (I)

ramosetron iv at recovery (R)

Arm Description

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

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

Outcomes

Primary Outcome Measures

QTc interval change

Difference of QTc interval from preoperative value

Secondary Outcome Measures

Full Information

NCT ID

NCT03278522

First Posted

September 6, 2017

Last Updated

March 7, 2018

Sponsor

Konkuk University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03278522

Brief Title

Ramosetron Pre-treatment for PONV and QT Prolongation

Official Title

Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konkuk University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PONV, Prolonged QTc Interval

Keywords

ramosetron

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ramosetron iv at induction (I)

Arm Type

Active Comparator

Arm Description

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

Arm Title

ramosetron iv at recovery (R)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ramosetron

Other Intervention Name(s)

ramosetron pre-treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

QTc interval change

Description

Difference of QTc interval from preoperative value

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients who underwent laparoscopic gynecologic surgery Exclusion Criteria: preoperative bradyarrhythmia in ECG

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ka Young Rhee, MD,PhD

Organizational Affiliation

Konkuk University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lee Sung Ho

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Ramosetron Pre-treatment for PONV and QT Prolongation

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