Clinical trial NCT03539003: The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Robotic-assisted Laparoscopic Radical Prostatectomy Under Sevoflurane, Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Official title: The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Robotic-assisted Laparoscopic Radical Prostatectomy Under Sevoflurane, Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic-assisted Laparoscopic Radical Prostatectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 69
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. sevoflurane group
2. desflurane group
3. total intravenous anesthesia group
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the changes of QTc, Tp-e interval, and Tp-e/QT ratio, Tp-e/QTc ratio on the ECG during robotic-assisted laparoscopic radical prostatectomy under sevoflurane, desflurane and total intravenous anesthesia


Eligibility criteria: Inclusion Criteria:

1. ASA class I-III
2. patients undergoing elective robot-assisted laparoscopic radical prostatectomy
3. adult (≥19 years old)

Exclusion Criteria:

1. emergency surgery
2. preoperative QTc prolongation
3. Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
4. uncontrolled hypertension (DBP \>110 mmHg)
5. Patients who take beta blocker
6. Ventricular conduction abnormality
7. Hepatic or renal failure
8. Drug hyperactivity
9. patients unable to understand informed consent (foreigner, illiteracy..)

Primary outcomes:
measure: heart-rate corrected QT(QTc) interval
timeFrame: participants will be followed for the duration of surgery, an expected average of 4 hours.
Secondary outcomes:
measure: Tp-e interval
timeFrame: Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8)
measure: Tp-e/QT ratio
timeFrame: Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8)
measure: Tp-e/QTc ratio
timeFrame: Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8)
measure: Heart rate
timeFrame: Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8)
measure: blood pressure
timeFrame: Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
state: Korea
Study officials:
References: