Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

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

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

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders; Inhalation; Vapor
• Intervention / Treatment: Other: General anesthesia with high fresh gas flow; Diagnostic test: Mini mental state examination; Diagnostic test: Visual Analogue Scale; Other: General anesthesia with low fresh gas flow

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 Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Prof. Dr. Cemil Taşçıoğlu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohorts were selected from geriatric patients (>65 y.o.) of a tertiary care clinic who underwent surgery under general anesthesia with different fresh gas flows for the maintenance phase.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour	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).	Baseline and postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour	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).	Baseline and postoperative hour 6
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day	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).	Baseline and postoperative day 3
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day	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).	Baseline and postoperative day 7
Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour	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	Baseline and postoperative hour 6
Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour	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	Baseline and postoperative hour 24
Change from baseline in pain on the 10 point VAS scale at postoperative 3rd day	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	Baseline and postoperative day 3
Change from baseline in pain on the 10 point VAS scale at postoperative 7th day	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	Baseline and postoperative day 7

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Namigar TURGUT, Prof. Dr. Cemil Taşçıoğlu City Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No