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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02536014
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02536014
• Other Study ID Numbers: 4-2015-0337
• First Posted: Aug 31, 2015
• Last Update Posted: Jan 29, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Yonsei University: Dexmedetomidine; pneumoperitoneum; trendelenburg position; QTc interval; Tp-e interval; robotic prostatectomy
• Additional relevant MeSH terms: Prostatic Neoplasms; Dexmedetomidine

Study Results

No Results Posted as of Jan 29, 2016