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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02536014

Enrollment

Registered

2015-08-31

Start date

2015-08-31

Completion date

2016-01-31

Last updated

2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Robotic Surgery

Keywords

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

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.

Interventions

DRUGSaline

Saline infusion during the same time period

DRUGDexmedetomidine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026