Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

September 17, 2022 updated by: Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and postoperative day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and postoperative hour 6
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).
Baseline and postoperative day 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).
Baseline and postoperative day 7
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
Baseline and postoperative hour 6
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
Baseline and postoperative hour 24
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
Baseline and postoperative day 3
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
Baseline and postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Namigar TURGUT, Prof. Dr. Cemil Taşcıoğlu City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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