Cognitive Dysfunction, Cognitive DisorderNCT06597812
the Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium
An observational study of Cognitive Dysfunction, Cognitive Disorder and Delirium - Postoperative, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated. There is no harm to the patient. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Cognitive Disorder, Delirium - Postoperative
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Nov 2023
- How long will I take part?
- 1 Day
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 60 years of age who are scheduled for laparoscopic cholecystectomy
Who may be able to join
- There was a correlation between the incidence of delirium after the age of 60(10).
Who cannot join
- Patients' age\< 60 years,
- Patients undergoing emergency cholecystectomy or did not have preoperative Mini-Cog assessment,
- With a history of cerebrovaskuler insult that was thought to have an effect on postoperative delirium ,
- Patients with difficulty in cooperation ,
- Patients with hemodynamic instability(arterial blood pressure above 160/90 mmHg and below 90/60 mmHg and patients with pulse rate below 50/min and above 100/min) ,
- Patients with previously diagnosed dementia, and those who had surgical procedures lasting more than 2 hours were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium in Elderly Patient With Low Preoperative Mini-cog Score
In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated. There is no harm to the patient.
Read the detailed description
The patients were preoperatively assessed for American Society of Anesthesiologists (ASA) risk by an anesthetist and age, sex and comorbidities were recorded. The Mini-cog test was applied as a cognitive screening test by the anesthesiologist in the preoperative period and the test score was recorded. Three-word memory test, clock drawing, and visual function test was performed to evaluate the patient's cognitive functions. In this test, patients were asked to memorize three words such as umbrella, sunshine, and chair at the beginning of the test.
- Being tested
- Sevoflurane
- Keywords
- delirium, Mini-Cog, anaesthesia
- Medical subject headings
- Cognitive Dysfunction, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneProcedure or surgery
Depending on the anesthesia maintenance protocol, total intravenous anesthesia (TIVA) or sevoflurane anesthesia, patients were divided into group T (TIVA) and group S (sevoflurane).
| Study group | Role | What they receive |
|---|---|---|
| group s | Patients receiving sevoflurane Receives: Procedure: Sevoflurane | |
| Group p | Patients receiving propofol-based total intravenous anesthesia Receives: Procedure: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group P-S
Incidence of postoperative delirium in patients receiving sevoflurane or propofol-based total intravenous anesthesia
Measured: postoperative 0 1st 2nd hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive Dysfunction, Cognitive DisorderStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Tolga Duran, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597812
- Sponsor's protocol ID
- 2023/11
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I approve the usability in multicenter studies in the study plan population
Publications
Fiamanya S, Ma S, Yates DRA. The association between preoperative Mini-Cog(c) score and postoperative delirium (POD): a retrospective cohort study. Perioper Med (Lond). 2022 Apr 21;11(1):16. doi: 10.1186/s13741-022-00249-0.
PubMed 35443735Jing GW, Xie Q, Tong J, Liu LZ, Jiang X, Si L. Early Intervention of Perioperative Delirium in Older Patients (>60 years) with Hip Fracture: A Randomized Controlled Study. Orthop Surg. 2022 May;14(5):885-891. doi: 10.1111/os.13244. Epub 2022 Apr 19.
PubMed 35441485Racine AM, Fong TG, Gou Y, Travison TG, Tommet D, Erickson K, Jones RN, Dickerson BC, Metzger E, Marcantonio ER, Schmitt EM, Inouye SK. Clinical outcomes in older surgical patients with mild cognitive impairment. Alzheimers Dement. 2018 May;14(5):590-600. doi: 10.1016/j.jalz.2017.10.010. Epub 2017 Nov 27.
PubMed 29190460Duran HT, Kizilkaya M, Aydinli A, Osmantevfik S, Tastan S, Kilinc OO, Pirhan Y. The effect of two different modes of anaesthesia maintenance on postoperative delirium in elderly patient with low preoperative mini-cog score. BMC Anesthesiol. 2024 Oct 1;24(1):350. doi: 10.1186/s12871-024-02735-y.
PubMed 39354373
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium in Elderly Patient With Low Preoperative Mini-cog Score
- ClinicalTrials.gov ID
- NCT06597812
- Acronym / sponsor ID
- 2023/11
- Keywords
- delirium, Mini-Cog, anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 19 Sep 2024 (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.
In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated. There is no harm to the patient.
Detailed description
The patients were preoperatively assessed for American Society of Anesthesiologists (ASA) risk by an anesthetist and age, sex and comorbidities were recorded. The Mini-cog test was applied as a cognitive screening test by the anesthesiologist in the preoperative period and the test score was recorded. Three-word memory test, clock drawing, and visual function test was performed to evaluate the patient's cognitive functions. In this test, patients were asked to memorize three words such as umbrella, sunshine, and chair at the beginning of the test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group s | – | Procedure: SevofluranePatients receiving sevoflurane |
| Group p | – | Procedure: SevofluranePatients receiving propofol-based total intravenous anesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 60 years of age who are scheduled for laparoscopic cholecystectomy
Key inclusion criteria (1 listed)
- There was a correlation between the incidence of delirium after the age of 60(10).
Key exclusion criteria (6 listed)
- Patients' age\< 60 years,
- Patients undergoing emergency cholecystectomy or did not have preoperative Mini-Cog assessment,
- With a history of cerebrovaskuler insult that was thought to have an effect on postoperative delirium ,
- Patients with difficulty in cooperation ,
- Patients with hemodynamic instability(arterial blood pressure above 160/90 mmHg and below 90/60 mmHg and patients with pulse rate below 50/min and above 100/min) ,
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 |
|---|---|---|
| SevofluraneDepending on the anesthesia maintenance protocol, total intravenous anesthesia (TIVA) or sevoflurane anesthesia, patients were divided into group T (TIVA) and group S (sevoflurane). | Procedure or surgery | Group p, group s |
Primary outcome
Group P-S
Time frame: postoperative 0 1st 2nd hours
Incidence of postoperative delirium in patients receiving sevoflurane or propofol-based total intravenous anesthesia
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 19 Sep 2024.
- Results publication: PubMed 35443735Fiamanya S, Ma S, Yates DRA. The association between preoperative Mini-Cog(c) score and postoperative delirium (POD): a retrospective cohort study. Perioper Med (Lond). 2022 Apr 21;11(1):16. doi: 10.1186/s13741-022-00249-0.
- Results publication: PubMed 35441485Jing GW, Xie Q, Tong J, Liu LZ, Jiang X, Si L. Early Intervention of Perioperative Delirium in Older Patients (>60 years) with Hip Fracture: A Randomized Controlled Study. Orthop Surg. 2022 May;14(5):885-891. doi: 10.1111/os.13244. Epub 2022 Apr 19.
- Results publication: PubMed 29190460Racine AM, Fong TG, Gou Y, Travison TG, Tommet D, Erickson K, Jones RN, Dickerson BC, Metzger E, Marcantonio ER, Schmitt EM, Inouye SK. Clinical outcomes in older surgical patients with mild cognitive impairment. Alzheimers Dement. 2018 May;14(5):590-600. doi: 10.1016/j.jalz.2017.10.010. Epub 2017 Nov 27.
- Derived from this study: PubMed 39354373Duran HT, Kizilkaya M, Aydinli A, Osmantevfik S, Tastan S, Kilinc OO, Pirhan Y. The effect of two different modes of anaesthesia maintenance on postoperative delirium in elderly patient with low preoperative mini-cog score. BMC Anesthesiol. 2024 Oct 1;24(1):350. doi: 10.1186/s12871-024-02735-y.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I approve the usability in multicenter studies in the study plan population
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cognitive Dysfunction, Cognitive Disorder and Delirium - Postoperative, run by Amasya University 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 1 inclusion and 6 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 19 Sep 2024. 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?
Group P-S (time frame: postoperative 0 1st 2nd hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597812, which also lists 4 linked publications.
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 19 Sep 2024.