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

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536014
• Other study ID #: 4-2015-0337
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: January 27, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. ASA class I-II

2. Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy

Exclusion Criteria:

1. Emergency operation

2. Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)

3. Ventricular conduction abnormality

4. Prior pacemaker insertion

5. Abnormal electrolyte values

6. Patients who take antiarrythmic agent

7. Hepatic or renal failure

8. Drug hyperactivity

9. Neurological or psychiatric illnesses

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Robotic Surgery

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine infusion (0.3?/kg/hr) from anesthetic induction to the end of pneumoperitoneum
• Saline
Saline infusion during the same time period

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dexmedetomidine on heart-rate corrected QT(QTc) interval	QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum	From pre-induciton until 60 min after the end of pneumoperitoneum	Yes