Neurocognitive DisordersNCT05548998
Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly
An observational study of Neurocognitive Disorders and Inhalation; Vapor, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders, Inhalation; Vapor
- What is being tested?
- General anesthesia with low fresh gas flow, General anesthesia with high fresh gas flow and Mini mental state examination
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Age>65
- Consenting to participate
- Scheduled for surgery longer than 2 hours under GA
- Able to read and write
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, 34384
About this study
Official title: 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
Read the 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.
- Conditions
- Neurocognitive Disorders, Inhalation; Vapor
- Being tested
- General anesthesia with low fresh gas flow, General anesthesia with high fresh gas flow, Mini mental state examination, Visual Analogue Scale
- Medical subject headings
- Neurocognitive Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia with low fresh gas flowOther
General anesthesia with a fresh gas flow lower than 1L/min for the maintenance phase of anesthesia
General anesthesia with high fresh gas flowOther
General anesthesia with a fresh gas flow equal to or higher than 1L/min for the maintenance phase of anesthesia
Mini mental state examinationDiagnostic test
Also called MMSE
6 category and 30-point test to inquire patient's cognitive function
Visual Analogue ScaleDiagnostic test
Also called VAS
The patient's self-reported pain intensity according to a visual scale between 0 and 100
| Study group | Role | What they receive |
|---|---|---|
| High flow cohort (HFA) | Patients, whose maintenance phase of anesthesia is managed with a fresh gas flow ≥ 1L/min, were included in this cohort. Receives: 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. Receives: Other: General anesthesia with low fresh gas flow; Diagnostic Test: Mini mental state examination; Diagnostic Test: Visual Analogue Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and postoperative day 1
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Namigar TURGUT, Principal investigator, Prof. Dr. Cemil Taşcıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548998
- Sponsor's protocol ID
- 1206
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients
- ClinicalTrials.gov ID
- NCT05548998
- Acronym / sponsor ID
- 1206
- Conditions
- Neurocognitive Disorders, Inhalation; Vapor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow cohort (HFA) | – | Other: General anesthesia with high fresh gas flow, Diagnostic Test: Mini mental state examination, Diagnostic Test: Visual Analogue ScalePatients, whose maintenance phase of anesthesia is managed with a fresh gas flow ≥ 1L/min, were included in this cohort. |
| Low flow cohort (LFA) | – | Other: General anesthesia with low fresh gas flow, Diagnostic Test: Mini mental state examination, Diagnostic Test: Visual Analogue ScalePatients, whose maintenance phase of anesthesia is managed with a fresh gas flow < 1L/min, were included in this cohort. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- Age>65
- Consenting to participate
- Scheduled for surgery longer than 2 hours under GA
- Able to read and write
Key exclusion criteria (11 listed)
- Age<65
- Refusing to participate
- Existing visual impairment preventing the patient from reading or writing
- Unable to read and write
- Existing major neurocognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesia with low fresh gas flowGeneral anesthesia with a fresh gas flow lower than 1L/min for the maintenance phase of anesthesia | Other | Low flow cohort (LFA) |
| General anesthesia with high fresh gas flowGeneral anesthesia with a fresh gas flow equal to or higher than 1L/min for the maintenance phase of anesthesia | Other | High flow cohort (HFA) |
| Mini mental state examinationAlso: MMSE6 category and 30-point test to inquire patient's cognitive function | Diagnostic test | High flow cohort (HFA), Low flow cohort (LFA) |
| Visual Analogue ScaleAlso: VASThe patient's self-reported pain intensity according to a visual scale between 0 and 100 | Diagnostic test | High flow cohort (HFA), Low flow cohort (LFA) |
Primary outcome
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).
7 secondary outcomes
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour
Time frame: 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
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day
Time frame: 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
Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour
Time frame: 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
Change from baseline in pain on the 10 point VAS scale at postoperative 7th day
Time frame: Baseline and postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namigar TURGUT principal investigator
Prof. Dr. Cemil Taşcıoğlu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders and Inhalation; Vapor, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour (time frame: Baseline and postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.