Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia

September 2, 2020 updated by: Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital

Power Spectral Analysis of the Electroencephalogram During Equi-MAC Sevoflurane vs. Desflurane Anesthesia: A Randomized Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectral edge frequency 95% value
Time Frame: During about 30 min study period
EEG variables were measured after meeting steady-state anesthesia of 1 MAC.
During about 30 min study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral index
Time Frame: During about 30 min study period
Bispectral index measurements were made after meeting steady-state anesthesia of 1 MAC.
During about 30 min study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2016

Primary Completion (Actual)

December 6, 2016

Study Completion (Actual)

December 6, 2016

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBSMC 2016-07-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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