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

NCT03539003 | Completed

• 1 other identifier: 4-2018-0296
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Robotic-assisted Laparoscopic Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (3)

sevoflurane (Group S)

EXPERIMENTAL

general anesthesia with sevoflurane

Drug: sevoflurane

desflurane (Group D)

ACTIVE COMPARATOR

general anesthesia with desflurane

Drug: desflurane

total intravenous anesthesia (Group T)

ACTIVE COMPARATOR

general anesthesia with total intravenous anesthesia

Drug: propofol and remifentanil

Interventions

sevoflurane DRUG

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.

Also known as: Group S

sevoflurane (Group S)

desflurane DRUG

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.

Also known as: Group D

desflurane (Group D)

propofol and remifentanil DRUG

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.

Also known as: Group T

total intravenous anesthesia (Group T)

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Patients undergoing robotic-assisted laparoscopic radical prostatectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I-III
• patients undergoing elective robot-assisted laparoscopic radical prostatectomy
• adult (≥19 years old)

You may not qualify if:

• 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..)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Korea, 03722, South Korea

Location

MeSH Terms

Interventions

Sevoflurane; Desflurane; Propofol; Remifentanil; Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. sevoflurane group 2. desflurane group 3. total intravenous anesthesia group

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 31, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)