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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-

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536014
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Robotic Surgery Drug: Dexmedetomidine Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : August 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum

Active Comparator: Saline Drug: Saline
Saline infusion during the same time period




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536014


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02536014    
Other Study ID Numbers: 4-2015-0337
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by Yonsei University:
Dexmedetomidine
pneumoperitoneum
trendelenburg position
QTc interval
Tp-e interval
robotic prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action