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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-

Yonsei University logo

Yonsei University

Status

Completed

Conditions

Prostate Cancer
Robotic Surgery

Treatments

Drug: Saline
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02536014
4-2015-0337

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Male

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

Dexmedetomidine
Experimental group
Treatment:
Drug: Dexmedetomidine
Saline
Active Comparator group
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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