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Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02872389
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
3.7
Actual Duration (Months)
24.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there were no studies that demonstrate the difference of hypnotic potency using power spectral analysis of electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of each bandage). The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Power Spectral Analysis of the Electroencephalogram During Equi-MAC Sevoflurane vs. Desflurane Anesthesia: A Randomized Controlled Trial
Actual Study Start Date :
Aug 16, 2016
Actual Primary Completion Date :
Dec 6, 2016
Actual Study Completion Date :
Dec 6, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sevoflurane

Anesthesia was maintained with sevoflurane.

Drug: Sevoflurane
Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
Other Names:
  • SEVO

    		•
    Experimental: Desflurane

    Anesthesia was maintained with desflurane.

    Drug: Desflurane
    Anesthesia was maintained with desflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
    Other Names:
  • DES

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Spectral edge frequency 95% value [During about 30 min study period]

      EEG variables were measured after meeting steady-state anesthesia of 1 MAC.

    Secondary Outcome Measures

    1. Bispectral index [During about 30 min study period]

      Bispectral index measurements were made after meeting steady-state anesthesia of 1 MAC.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients undergoing arthroscopic knee surgery under general anesthesia using volatile anesthetics

    • patients with american society of anesthesiologist physical status I, II

    • patients aged 19-65 years

    • patients obtaining written informed consent

    Exclusion Criteria:

    • patients with a history of any psychiatric or neurological disease

    • patients who had received any medication affecting the central nervous system

    • patients who had received medication affecting the sympathetic or parasympathetic nervous systems

    • patients undergoing tracheal intubation for airway management

    • pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181

    Sponsors and Collaborators

    • Kangbuk Samsung Hospital

    Investigators

    • Principal Investigator: Kyoungho Ryu, M.D., Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyoung-Ho Ryu, MD, Clinical assistant professor, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT02872389
    Other Study ID Numbers:
    • KBSMC 2016-07-033
    First Posted:
    Aug 19, 2016
    Last Update Posted:
    Sep 3, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Sevoflurane
    Desflurane

    Study Results

    No Results Posted as of Sep 3, 2020