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

NCT02586441 | Unknown Phase 4 DMC

• 1 other identifier: MD11004
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

Bispectral index (BIS); EEG; Depth of anesthesia

Outcome Measures

Primary Outcomes (1)

• EEG acquisition

  Raw 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

  From 5minutes before induction to extubation

Study Arms (1)

Electroencephalography

EXPERIMENTAL

1. Standard monitoring included electrocardiogram, noninvasive arterial blood pressure, pulse oximetry, and BIS-VISTATM sensor at OR. 2. Raw EEG in a steady state was collected for 5 minutes. 3. Anesthesia was induced with intravenous 1% propofol (1.5-2.5 mg/kg) and rocuronium bromide (0.6 mg/kg) 4. Mechanical ventilation was initiated 5. Anesthesia was maintained with desflurane at an end-tidal concentration of 6-7 %, with a fraction of inspired oxygen of 0.5 (fresh gas flow; O2 1.5 L/min and air 2.5 L/min). 6. On completion of the surgery, all anesthetic gases were discontinued and the FiO2 was increased to 1.0. 7. After extubation, BIS-VISTA TM monitoring was stopped.

Device: Electroencephalography; Drug: Propofol; Drug: Rocuronium bromide

Interventions

Electroencephalography DEVICE

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

Electroencephalography

Propofol DRUG

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

Also known as: Fresofol MCT 1%

Electroencephalography

Rocuronium bromide DRUG

intravenous rocuronium bromide (0.6 mg/kg)

Also known as: Esmerone

Electroencephalography

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Related Publications (1)

• Yoon YG, Kim TH, Jeong DW, Park SH. Monitoring the depth of anesthesia from rat EEG using modified Shannon entropy analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:4386-9. doi: 10.1109/IEMBS.2011.6091088.

  PMID: 22255311 RESULT

MeSH Terms

Interventions

Electroencephalography; Propofol; Rocuronium

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hyub Huh, M.D

  Anesthesia and Pain medicine department, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyub Huh, M.D

CONTACT

+82 - 10 - 6212 -9105; clumania@hanmail.net

Joonchul Jang, M.D

CONTACT

+82 - 10 - 9127 -9097; gratefull84@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 26, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: November 4, 2015

Record last verified: 2015-11