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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03539003
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Robotic-assisted Laparoscopic Radical Prostatectomy	Drug: sevoflurane; Drug: desflurane; Drug: propofol and remifentanil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: sevoflurane group desflurane group total intravenous anesthesia groupsevoflurane group desflurane group total intravenous anesthesia group
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 31, 2018
• Actual Primary Completion Date: Jan 22, 2019
• Actual Study Completion Date: Jan 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sevoflurane (Group S) general anesthesia with sevoflurane	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.; Other Names: Group S
Active Comparator: desflurane (Group D) general anesthesia with desflurane	Drug: 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.; Other Names: Group D
Active Comparator: total intravenous anesthesia (Group T) general anesthesia with total intravenous anesthesia	Drug: 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.; Other Names: Group T

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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..)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul	Korea	Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03539003
• Other Study ID Numbers: 4-2018-0296
• First Posted: May 29, 2018
• Last Update Posted: Feb 11, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Remifentanil; Propofol; Sevoflurane; Desflurane

Study Results

No Results Posted as of Feb 11, 2019