Robotic-assisted Laparoscopic Radical Prostatectomy
Conditions
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
Interventions
DRUGsevoflurane
anesthesia was induced with propofol (1.5 mg/kg) and target controlled infusion (TCI) of remifentanil (2-3 ng/mL of targeted effect site concentration (Ce). After intubation, inspired concentration of sevoflurane (0.8-1 MAC) and the Ce of remifentanil TCI (1.0-2.0 ng/ml) were adjusted to a BIS target level for hypnosis of 40-60 during surgery.
DRUGdesflurane
anesthesia was induced with propofol (1.5 mg/kg) and target controlled infusion (TCI) of remifentanil (2-3 ng/mL of targeted effect site concentration (Ce). After intubation, inspired concentration of desflurane (0.8-1 MAC) and the Ce of remifentanil TCI (1.0-2.0 ng/ml) were adjusted to a BIS target level for hypnosis of 40-60 during surgery.
anesthesia was induced with an effect-site concentration of 3-4 μg/ml propofol and 2-3 ng/ml remifentanil using target-controlled infusion (TCI). After intubation, The effect site TCI of propofol (2-3 μg/ml) and remifentanil (1.0-2.0 ng/ml) was adjusted to maintain the desired hypnosis (40-60 of the BIS value) during surgery.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1. sevoflurane group 2. desflurane group 3. total intravenous anesthesia group
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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..)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| heart-rate corrected QT(QTc) interval | participants will be followed for the duration of surgery, an expected average of 4 hours. | QTc intervals (msec) are recorded from ECG |
Secondary
| Measure | Time frame |
|---|---|
| Tp-e interval | 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) |
| Tp-e/QT ratio | 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) |
| Tp-e/QTc ratio | 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) |
| Heart rate | 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) |
| blood pressure | 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) |
Countries
South Korea
Outcome results
None listed