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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02586441
• Other study ID #: MD11004
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 23, 2015
• Last updated: November 2, 2015
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Korea University Anam Hospital
• Contact: Hyub Huh, M.D
• Phone: +82 - 10 - 6212 -9105
• Email: clumania[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia

Intervention

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)
• Rocuronium bromide
intravenous rocuronium bromide (0.6 mg/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No