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Completed

NCT Number: NCT05548998

Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

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

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Key information

Conditions

Neurocognitive Disorders Inhalation; Vapor Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anesthesia with low fresh gas flow

Other

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

General anesthesia with high fresh gas flow

Other

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

Mini mental state examination

Diagnostic Test

6 category and 30-point test to inquire patient's cognitive function

Other names: MMSE

Visual Analogue Scale

Diagnostic Test

The patient's self-reported pain intensity according to a visual scale between 0 and 100

Other names: VAS

Primary outcomes

  1. Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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