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

Not Applicable

Completed

• Conditions: Robotic-assisted Laparoscopic Radical Prostatectomy
• Interventions: Drug: propofol and remifentanil; Drug: sevoflurane; Drug: desflurane

• Registration Number: NCT03539003
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-29
• Study Start: 2018-05-31
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 69

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..)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total intravenous anesthesia (Group T)	propofol and remifentanil	general anesthesia with total intravenous anesthesia
sevoflurane (Group S)	sevoflurane	general anesthesia with sevoflurane
desflurane (Group D)	desflurane	general anesthesia with desflurane

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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)
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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Korea, Republic of