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Evaluation of EEG With Respect to the Change of Depth of Anesthesia During General Anesthesia

Evaluation of EEG With Respect to the Change of Depth of Anesthesia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02586441
Enrollment
40
Registered
2015-10-26
Start date
2015-11-30
Completion date
2017-11-30
Last updated
2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Bispectral index (BIS), EEG, Depth of anesthesia

Brief summary

The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported. Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.

Detailed description

General anesthesia is accompanied during surgery gives a lot of satisfaction and impact on surgical outcomes of patients depending on the dose of the anesthetic, as well as operation time and intensity. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents;and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. However, this equipment does not give the proper anesthetic depth index is a number of experimental results have been reported. Therefore, the investigators study that the BIS VISTA receives an electroencephalogram (EEG) obtained through the depth of anesthesia monitors brain waves to collect statistical data, through mathematical analysis to analyze the exact correlation between the patient's brain waves and the depth of anesthesia.

Interventions

DEVICEElectroencephalography

Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during all anesthetic period.

DRUGPropofol

intravenous 1% propofol (1.5-2.5 mg/kg)

DRUGRocuronium bromide

intravenous rocuronium bromide (0.6 mg/kg)

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* American Society of Anesthesiologist\[ASA\] class 1-2 * written informed consent

Exclusion criteria

* allergy of neuromuscular blocking drugs or other medications used during general anesthesia * known or suspected upper respiratory infection * suspected difficult tracheal intubation * Uncontrolled Hypertension * known or suspected psychologic disorder * known or suspected significant renal dysfunction * known or suspected severe hepatic dysfunction * known or suspected significant cardiovascular dysfunction

Design outcomes

Primary

MeasureTime frameDescription
EEG acquisitionFrom 5minutes before induction to extubationRaw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during intraoperative period. Transferring the raw EEG signal obtained from BIS VISTA monitor to a computer, the data is processed using MATLAB

Contacts

Primary ContactHyub Huh, M.D
clumania@hanmail.net+82 - 10 - 6212 -9105
Backup ContactJoonchul Jang, M.D
gratefull84@naver.com+82 - 10 - 9127 -9097

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026