Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

NCT ID: NCT05548998

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-11-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Neurocognitive Disorders Inhalation; Vapor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High flow cohort (HFA)

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

General anesthesia with high fresh gas flow

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Visual Analogue Scale

Intervention Type DIAGNOSTIC_TEST

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

Low flow cohort (LFA)

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

General anesthesia with low fresh gas flow

Intervention Type OTHER

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

Mini mental state examination

Intervention Type DIAGNOSTIC_TEST

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

Visual Analogue Scale

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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General anesthesia with low fresh gas flow

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

Intervention Type 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

Intervention Type OTHER

Mini mental state examination

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

Intervention Type DIAGNOSTIC_TEST

Visual Analogue Scale

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MMSE VAS

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Namigar Turgut

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Namigar TURGUT

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Cemil Taşcıoğlu City Hospital

Locations

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Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1206

Identifier Type: -

Identifier Source: org_study_id

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