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

Not Applicable

Completed

• Conditions: Prostate Cancer; Robotic Surgery
• Interventions: Drug: Saline; Drug: Dexmedetomidine

• Registration Number: NCT02536014
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-14
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-08-31
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of