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

NCT02536014 | Completed

• 1 other identifier: 4-2015-0337
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Robotic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dexmedetomidine on heart-rate corrected QT(QTc) interval

  QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum

  From pre-induciton until 60 min after the end of pneumoperitoneum

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Saline

ACTIVE COMPARATOR

Drug: Saline

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Saline DRUG

Saline infusion during the same time period

Saline

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pneumoperitoneum

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: August 31, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

KR (1)