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

NCT ID: NCT02586441

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electroencephalography

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.

Group Type: EXPERIMENTAL

Electroencephalography

Intervention Type: DEVICE

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

Propofol

Intervention Type: DRUG

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

Rocuronium bromide

Intervention Type: DRUG

intravenous rocuronium bromide (0.6 mg/kg)

Interventions

Electroencephalography

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

Intervention Type: DEVICE

Propofol

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

Intervention Type: DRUG

Rocuronium bromide

intravenous rocuronium bromide (0.6 mg/kg)

Intervention Type: DRUG

Other Intervention Names

Fresofol MCT 1%; Esmerone

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joonchul Jang

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyub Huh, M.D

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Pain medicine department, Korea University Anam Hospital

Central Contacts

Hyub Huh, M.D

Role: CONTACT

clumania@hanmail.net

+82 - 10 - 6212 -9105

Joonchul Jang, M.D

Role: CONTACT

gratefull84@naver.com

+82 - 10 - 9127 -9097

References

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.

Reference Type: RESULT

PMID: 22255311 (View on PubMed)

Other Identifiers

MD11004

Identifier Type: -

Identifier Source: org_study_id