Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
Overall Status
Completed
CT.gov ID
NCT05548998
Collaborator
(none)
230
1
6
38

Study Details

Study Description

Brief Summary

This study aims to investigate the effect of inhaled anesthetics with a low fresh gas flow on cognitive function of elderly patients undergoing elective surgery

Condition or Disease Intervention/Treatment Phase
  • Other: General anesthesia with low fresh gas flow
  • Other: General anesthesia with high fresh gas flow
  • Diagnostic Test: Mini mental state examination
  • Diagnostic Test: Visual Analogue Scale

Detailed Description

Geriatric patients scheduled to undergo surgery were tested with Mini Mental State Examination (MMSE) in the preoperative visit. MMSE was repeated postoperatively at the 6th hour, the 1st, 3rd, and 7th day. Visual analogue scale (VAS) test was performed simultaneously on the postoperative 6th hour, the 1st, 3rd, and 7th day. Two cohorts were created according to the amount of fresh gas flow (low flow vs high flow) in the maintenance phase of the inhalational anesthetic. MMSE scores were compared between cohorts and baseline. VAS scores were compared between cohorts.

Study Design

Study Type:
Observational
Actual Enrollment :
230 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
High flow cohort (HFA)

Patients, whose maintenance phase of anesthesia is managed with a fresh gas flow ≥ 1L/min, were included in this cohort.

Other: General anesthesia with high fresh gas flow
General anesthesia with a fresh gas flow equal to or higher than 1L/min for the maintenance phase of anesthesia

Diagnostic Test: Mini mental state examination
6 category and 30-point test to inquire patient's cognitive function
Other Names:
  • MMSE
  • Diagnostic Test: Visual Analogue Scale
    The patient's self-reported pain intensity according to a visual scale between 0 and 100
    Other Names:
  • VAS
  • Low flow cohort (LFA)

    Patients, whose maintenance phase of anesthesia is managed with a fresh gas flow < 1L/min, were included in this cohort.

    Other: General anesthesia with low fresh gas flow
    General anesthesia with a fresh gas flow lower than 1L/min for the maintenance phase of anesthesia

    Diagnostic Test: Mini mental state examination
    6 category and 30-point test to inquire patient's cognitive function
    Other Names:
  • MMSE
  • Diagnostic Test: Visual Analogue Scale
    The patient's self-reported pain intensity according to a visual scale between 0 and 100
    Other Names:
  • VAS
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour [Baseline and postoperative day 1]

      A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).

    Secondary Outcome Measures

    1. Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour [Baseline and postoperative hour 6]

      A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).

    2. Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day [Baseline and postoperative day 3]

      A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).

    3. Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day [Baseline and postoperative day 7]

      A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).

    4. Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour [Baseline and postoperative hour 6]

      The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge

    5. Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour [Baseline and postoperative hour 24]

      The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge

    6. Change from baseline in pain on the 10 point VAS scale at postoperative 3rd day [Baseline and postoperative day 3]

      The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge

    7. Change from baseline in pain on the 10 point VAS scale at postoperative 7th day [Baseline and postoperative day 7]

      The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age>65

    • Consenting to participate

    • Scheduled for surgery longer than 2 hours under GA

    • Able to read and write

    Exclusion Criteria:
    • Age<65

    • Refusing to participate

    • Existing visual impairment preventing the patient from reading or writing

    • Unable to read and write

    • Existing major neurocognitive disorder

    • Use of TIVA or regional techniques

    • Allergies to the volatile agents

    • Uncontrolled DM, acute alcohol intoxication

    • Conditions increasing tissue oxygen consumption (sepsis, thyrotoxicosis, etc.)

    • Anticipation/existence of major hemorrhage

    • Haemodynamic instability > 10 min or more than 5 times intraoperatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof. Dr. Cemil Taşcıoğlu City Hospital Istanbul Turkey 34384

    Sponsors and Collaborators

    • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    Investigators

    • Principal Investigator: Namigar TURGUT, Prof. Dr. Cemil Taşcıoğlu City Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Namigar Turgut, Professor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    ClinicalTrials.gov Identifier:
    NCT05548998
    Other Study ID Numbers:
    • 1206
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2022