search
Back to results

Glasgow Coma Scales and General Anesthesia

Primary Purpose

Anesthesia Awareness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bispectral index (BIS) monitoring
Sevoflurane
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia Awareness focused on measuring Bispectral index, Glasgow Coma Scale, intracranial pathology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 and 65 years
  • ASA II-III
  • intracranial surgery

Exclusion Criteria:

  • Patients with additional disease (electrolyte impairment, uremia, etc.),
  • liver and renal failure affecting consciousness level other than intracranial pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group I=13-15 mildly injured

    Group 2 =9-12 moderately damaged

    Group 3=3-8 severely damaged.

    Arm Description

    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group I (n=15)=13-15 mildly injured

    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 2 (n=15)=9-12 moderately damaged

    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 3 (n=15)=3-8 severely damaged.

    Outcomes

    Primary Outcome Measures

    BIS, Consumption of the inhalation agents
    Preoperative, intraoperative and postoperative BIS values were recorded. The total amount of opioid consumed was recorded from the infusion pump.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 24, 2018
    Last Updated
    May 9, 2018
    Sponsor
    Trakya University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03521414
    Brief Title
    Glasgow Coma Scales and General Anesthesia
    Official Title
    The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 3, 2013 (Actual)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    November 5, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study evaluates the general anesthesia management with BIS monitorization in terms of hemodynamic stability, drug concentrations and drug consumption in patients who underwent surgery due to intracranial pathology and who were divided in three different GCS groups.
    Detailed Description
    BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it can also be used for monitoring consciousness after resuscitation of cases with acute brain injury and cardiac arrest. It is not always possible to monitor and objectively measure the changes in the level of consciousness in clinical practice. Therefore, device-based methods have been introduced in monitoring the state of consciousness. Bispectral index (BIS) monitoring may be preferred in follow up of the state of consciousness in critical patients such as those with acute brain injury, in terms of ease of use, ability to obtain numerical results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia depth and sedation level, while it can also be applied for monitoring state of consciousness following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we aimed to investigate general anesthesia management performed by bispectral index monitoring in patients who underwent surgery due to intracranial pathology and with different Glasgow Coma Scales.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia Awareness
    Keywords
    Bispectral index, Glasgow Coma Scale, intracranial pathology

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I=13-15 mildly injured
    Arm Type
    Active Comparator
    Arm Description
    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group I (n=15)=13-15 mildly injured
    Arm Title
    Group 2 =9-12 moderately damaged
    Arm Type
    Active Comparator
    Arm Description
    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery.use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 2 (n=15)=9-12 moderately damaged
    Arm Title
    Group 3=3-8 severely damaged.
    Arm Type
    Active Comparator
    Arm Description
    Patients were divided into 3 groups according to the Glasgow Coma Scores calculated before surgery. use of anesthetic agent were recorded during bispectral index (BIS) monitoring and anesthesia application. we used sevoflurane drug intraoperative. Group 3 (n=15)=3-8 severely damaged.
    Intervention Type
    Device
    Intervention Name(s)
    Bispectral index (BIS) monitoring
    Intervention Description
    When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Description
    we used sevoflurane drug at inoperative
    Primary Outcome Measure Information:
    Title
    BIS, Consumption of the inhalation agents
    Description
    Preoperative, intraoperative and postoperative BIS values were recorded. The total amount of opioid consumed was recorded from the infusion pump.
    Time Frame
    200 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 and 65 years ASA II-III intracranial surgery Exclusion Criteria: Patients with additional disease (electrolyte impairment, uremia, etc.), liver and renal failure affecting consciousness level other than intracranial pathology

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Glasgow Coma Scales and General Anesthesia

    We'll reach out to this number within 24 hrs