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

K

Korea University

Status and phase

Unknown
Phase 4

Conditions

Anesthesia

Treatments

Device: Electroencephalography
Drug: Rocuronium bromide
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT02586441
MD11004

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Electroencephalography
Experimental group
Description:
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.
Treatment:
Drug: Propofol
Device: Electroencephalography
Drug: Rocuronium bromide

Trial contacts and locations

0

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Central trial contact

Joonchul Jang, M.D; Hyub Huh, M.D

Data sourced from clinicaltrials.gov

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