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

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.

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Key information

Conditions

Prostate Cancer Digestive System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Peritoneal Diseases Pneumoperitoneum Prostatic Diseases Prostatic Neoplasms Robotic Surgery Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Saline

Drug

Saline infusion during the same time period

Primary outcomes

Dexmedetomidine on heart-rate corrected QT(QTc) interval

Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 31, 2015
Registry last updated: Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed