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
NCT ID: NCT03539003
Last Updated: 2019-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2018-05-31
2019-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. desflurane group
3. total intravenous anesthesia group
PREVENTION
NONE
Study Groups
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sevoflurane (Group S)
general anesthesia with sevoflurane
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 (Group D)
general anesthesia with desflurane
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.
total intravenous anesthesia (Group T)
general anesthesia with total intravenous anesthesia
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. patients undergoing elective robot-assisted laparoscopic radical prostatectomy
3. adult (≥19 years old)
Exclusion Criteria
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..)
19 Years
MALE
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, South Korea
Countries
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Other Identifiers
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4-2018-0296
Identifier Type: -
Identifier Source: org_study_id
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