Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

NCT05548998 | Completed

• 1 other identifier: 1206
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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

Conditions

Neurocognitive Disorders; Inhalation; Vapor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Baseline and postoperative hour 6

• Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day

  Baseline and postoperative day 3

• Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day

  Baseline and postoperative day 7

• Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour

  Baseline and postoperative hour 6

• Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour

  Baseline and postoperative hour 24

Study Arms (2)

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; Diagnostic Test: Mini mental state examination; Diagnostic Test: Visual Analogue Scale

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; Diagnostic Test: Mini mental state examination; Diagnostic Test: Visual Analogue Scale

Interventions

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

Low flow cohort (LFA)

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

High flow cohort (HFA)

Mini mental state examination DIAGNOSTIC_TEST

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

Also known as: MMSE

High flow cohort (HFA); Low flow cohort (LFA)

Visual Analogue Scale DIAGNOSTIC_TEST

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

Also known as: VAS

High flow cohort (HFA); Low flow cohort (LFA)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Age\>65
• Consenting to participate
• Scheduled for surgery longer than 2 hours under GA
• Able to read and write

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Respiratory Aspiration

Interventions

Anesthesia, General; Pain Measurement

Condition Hierarchy (Ancestors)

Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Namigar TURGUT

  Prof. Dr. Cemil Taşcıoğlu City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: May 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)