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Completed

NCT Number: NCT03539003

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

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Key information

Conditions

Robotic-assisted Laparoscopic Radical Prostatectomy

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, Korea, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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..)

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Other names: Group T

Primary outcomes

  1. heart-rate corrected QT(QTc) interval

    Time frame: participants will be followed for the duration of surgery, an expected average of 4 hours.

    QTc intervals (msec) are recorded from ECG

Secondary outcomes

  1. Tp-e interval

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 29, 2018
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.