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

Robotic-assisted Laparoscopic Radical Prostatectomy Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539003
• Other study ID #: 4-2018-0296
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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..)

Related Conditions & MeSH terms

• Robotic-assisted Laparoscopic Radical Prostatectomy

Intervention

Drug:
• sevoflurane
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.
• desflurane
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.
• propofol and remifentanil
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)