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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Device: Electroencephalography; Drug: Propofol; Drug: Rocuronium bromide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electroencephalography; Standard monitoring included electrocardiogram, noninvasive arterial blood pressure, pulse oximetry, and BIS-VISTATM sensor at OR.; Raw EEG in a steady state was collected for 5 minutes.; Anesthesia was induced with intravenous 1% propofol (1.5-2.5 mg/kg) and rocuronium bromide (0.6 mg/kg); Mechanical ventilation was initiated; 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).; On completion of the surgery, all anesthetic gases were discontinued and the FiO2 was increased to 1.0.; After extubation, BIS-VISTA TM monitoring was stopped.

Device: Electroencephalography; Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during all anesthetic period.; Drug: Propofol; intravenous 1% propofol (1.5-2.5 mg/kg); Other Names: Fresofol MCT 1%; Drug: Rocuronium bromide; intravenous rocuronium bromide (0.6 mg/kg); Other Names: Esmerone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: Hyub Huh, M.D, Anesthesia and pain medicine department, Korea University Anam Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: EEG; Depth of anesthesia; Bispectral index (BIS)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Bromides; Rocuronium
• Other Study ID Numbers: MD11004