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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Robotic-assisted Laparoscopic Radical Prostatectomy

Intervention / Treatment
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* Drug: sevoflurane
* Drug: desflurane
* Drug: propofol and remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I-III patients undergoing elective robot-assisted laparoscopic radical prostatectomy adult (≥19 years old) Exclusion Criteria: emergency surgery preoperative QTc prolongation Cardiac disease (unstable angina, congestive heart failure, valvular heart disease) uncontrolled hypertension (DBP >110 mmHg) Patients who take beta blocker Ventricular conduction abnormality Hepatic or renal failure Drug hyperactivity patients unable to understand informed consent (foreigner, illiteracy..)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: sevoflurane group desflurane group total intravenous anesthesia group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane (Group S)<br>general anesthesia with sevoflurane | Drug: sevoflurane<br>* 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.<br>* Other names: Group S;|
| Active Comparator: desflurane (Group D)<br>general anesthesia with desflurane | Drug: desflurane<br>* 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.<br>* Other names: Group D;|
| Active Comparator: total intravenous anesthesia (Group T)<br>general anesthesia with total intravenous anesthesia | Drug: propofol and remifentanil<br>* 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.<br>* Other names: Group T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart-rate corrected QT(QTc) interval | QTc intervals (msec) are recorded from ECG | participants will be followed for the duration of surgery, an expected average of 4 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |