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

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

Study Overview

• Status: Completed
• Conditions: Robotic-assisted Laparoscopic Radical Prostatectomy
• Intervention / Treatment: Drug: sevoflurane; Drug: desflurane; Drug: propofol and remifentanil

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 03722
      • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2018
• Primary Completion (ACTUAL): January 22, 2019
• Study Completion (ACTUAL): January 22, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (ACTUAL): May 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Inhalation; Remifentanil; Propofol; Desflurane; Sevoflurane
• Other Study ID Numbers: 4-2018-0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No