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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-01-22

Brief Summary

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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

Detailed Description

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Conditions

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Robotic-assisted Laparoscopic Radical Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. sevoflurane group
2. desflurane group
3. total intravenous anesthesia group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sevoflurane (Group S)

general anesthesia with sevoflurane

Group Type EXPERIMENTAL

sevoflurane

Intervention Type 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.

desflurane (Group D)

general anesthesia with desflurane

Group Type ACTIVE_COMPARATOR

desflurane

Intervention Type 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.

total intravenous anesthesia (Group T)

general anesthesia with total intravenous anesthesia

Group Type ACTIVE_COMPARATOR

propofol and remifentanil

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Group S Group D Group T

Eligibility Criteria

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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..)
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, Korea, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2018-0296

Identifier Type: -

Identifier Source: org_study_id

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