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Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-

Primary Purpose

Prostate Cancer, Robotic Surgery

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dexmedetomidine

Saline

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Dexmedetomidine, pneumoperitoneum, trendelenburg position, QTc interval, Tp-e interval, robotic prostatectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

ASA class I-II
Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy

Exclusion Criteria:

Emergency operation
Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
Ventricular conduction abnormality
Prior pacemaker insertion
Abnormal electrolyte values
Patients who take antiarrythmic agent
Hepatic or renal failure
Drug hyperactivity
Neurological or psychiatric illnesses

Sites / Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine

Saline

Arm Description

Outcomes

Primary Outcome Measures

Dexmedetomidine on heart-rate corrected QT(QTc) interval

QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum

Secondary Outcome Measures

Full Information

NCT ID

NCT02536014

First Posted

July 14, 2015

Last Updated

January 27, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02536014

Brief Title

Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum. Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias. Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.

6. Conditions and Keywords

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

Prostate Cancer, Robotic Surgery

Keywords

Dexmedetomidine, pneumoperitoneum, trendelenburg position, QTc interval, Tp-e interval, robotic prostatectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Title

Saline

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Saline infusion during the same time period

Primary Outcome Measure Information:

Title

Dexmedetomidine on heart-rate corrected QT(QTc) interval

Description

QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum

Time Frame

From pre-induciton until 60 min after the end of pneumoperitoneum

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA class I-II Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy Exclusion Criteria: Emergency operation Cardiac disease (unstable angina, congestive heart failure, valvular heart disease) Ventricular conduction abnormality Prior pacemaker insertion Abnormal electrolyte values Patients who take antiarrythmic agent Hepatic or renal failure Drug hyperactivity Neurological or psychiatric illnesses

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-

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