Postoperative Cognitive Dysfunction (POCD)TCI-NEURONCT07311447
Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients
An observational study of Postoperative Cognitive Dysfunction (POCD) and Neurocognitive Function, run by Namigar Turgut at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effects of target-controlled infusion (TCI) on postoperative neurocognitive function in geriatric patients undergoing major non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction (POCD), Neurocognitive Function, Sedation and Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 31 Oct 2025
- 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: Geriatric patients aged 65 years and older who undergo noncardiac, nonneurosurgical major surgery under general anesthesia and are monitored postoperatively in the intensive care unit. The study includes patients managed with either Target Controlled Infusion (TCI) or manual infusion for postoperative sedation and analgesia.
Who may be able to join
- Patients aged 65 years and older
- Undergoing noncardiac, nonneurosurgical major surgery under general anesthesia
- Monitored postoperatively in the intensive care unit
- Provided informed consent to participate in the study
Who cannot join
- Cardiac or neurosurgical procedures
- Patients younger than 65 years
- Glasgow Coma Scale < 8
- No informed consent
- Body mass index (BMI) > 35
- Communication difficulties preventing cognitive testing
- Known allergy to study medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
About this study
Official title: The Effect of Target-Controlled Infusion (TCI) on Neurocognitive Functions in Postoperative Sedoanalgesia Management in Geriatric Patients Undergoing Major Surgery
This prospective observational study aims to evaluate the effects of target-controlled infusion (TCI) on postoperative neurocognitive function in geriatric patients undergoing major non-cardiac surgery. Elderly patients are at increased risk of postoperative cognitive dysfunction due to physiological changes and anesthesia-related factors. In this study, sedation management with TCI will be compared to manual infusion. Neurocognitive function will be assessed at multiple time points using the Mini-Mental State Examination (MMSE), and sedation levels will be monitored with the Bispectral Index (BIS) and the Richmond Agitation-Sedation Scale (RASS). The study aims to provide insights into safer sedation practices and improved cognitive outcomes in elderly surgical patients.
- Conditions
- Postoperative Cognitive Dysfunction (POCD), Neurocognitive Function, Sedation and Analgesia, Geriatric Patients
- Keywords
- Target-Controlled Infusion (TCI), Manual Infusion, Geriatric Patients, Mini-Mental State Examination (MMSE)
- Medical subject headings
- Postoperative Cognitive Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TCI Group | Patients receiving postoperative sedoanalgesia with Target-Controlled Infusion (TCI). Sedation and analgesia were maintained using a target-controlled infusion system adjusted according to BIS and RASS monitoring. | |
| Manual Infusion Group | Patients receiving postoperative sedoanalgesia with manually adjusted infusion without TCI. Sedation and analgesia were titrated manually based on BIS and RASS monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurocognitive function score (Mini-Mental State Examination,MMSE)
Between-group difference in the change of Mini-Mental State Examination (MMSE) total score from baseline to 72 hours after surgery, comparing target-controlled infusion (TCI) versus manual infusion. The MMSE is a widely used cognitive screening tool with a total score range of 0 to 30, where higher scores indicate better cognitive function.
Measured: Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperatively
Secondary outcomes (2)
Total sedative and analgesic drug consumption
Total amount of sedative and analgesic medications administered during the postoperative sedation period in both groups (TCI vs manual infusion). Lower consumption may indicate more efficient sedation management.
Measured: From admission to the intensive care unit (ICU) until completion of the postoperative sedation period (approximately 0-72 hours postoperatively).
Hospital length of stay
Total duration of hospitalization from the day of surgery until the patient is medically ready for discharge. Comparisons will be made between the TCI and manual infusion groups to evaluate whether postoperative sedation method influences overall hospital stay.
Measured: From the day of surgery until hospital discharge (up to 40 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start5 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction (POCD)Studies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namigar Turgut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Namigar Turgut, MD, Principal investigator, İstanbul Prof. Dr. Cemil Taşcıoğlu City HospitalZekeriya Ervatan, MD, Study chair, İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311447
- Sponsor's protocol ID
- Tascıoglu-TCI-POCD-2025
- Acronym
- TCI-NEURO
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Target-Controlled Infusion (TCI) on Neurocognitive Functions in Postoperative Sedoanalgesia Management in Geriatric Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT07311447
- Acronym / sponsor ID
- TCI-NEURO / Tascıoglu-TCI-POCD-2025
- Conditions
- Postoperative Cognitive Dysfunction (POCD), Neurocognitive Function, Sedation and Analgesia, Geriatric Patients
- Keywords
- Target-Controlled Infusion (TCI), Manual Infusion, Geriatric Patients, Mini-Mental State Examination (MMSE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Namigar TurgutUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 31 Dec 2025 (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 prospective observational study aims to evaluate the effects of target-controlled infusion (TCI) on postoperative neurocognitive function in geriatric patients undergoing major non-cardiac surgery. Elderly patients are at increased risk of postoperative cognitive dysfunction due to physiological changes and anesthesia-related factors. In this study, sedation management with TCI will be compared to manual infusion. Neurocognitive function will be assessed at multiple time points using the Mini-Mental State Examination (MMSE), and sedation levels will be monitored with the Bispectral Index (BIS) and the Richmond Agitation-Sedation Scale (RASS). The study aims to provide insights into safer sedation practices and improved cognitive outcomes in elderly surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI Group | – | –Patients receiving postoperative sedoanalgesia with Target-Controlled Infusion (TCI). Sedation and analgesia were maintained using a target-controlled infusion system adjusted according to BIS and RASS monitoring. |
| Manual Infusion Group | – | –Patients receiving postoperative sedoanalgesia with manually adjusted infusion without TCI. Sedation and analgesia were titrated manually based on BIS and RASS monitoring. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric patients aged 65 years and older who undergo noncardiac, nonneurosurgical major surgery under general anesthesia and are monitored postoperatively in the intensive care unit. The study includes patients managed with either Target Controlled Infusion (TCI) or manual infusion for postoperative sedation and analgesia.
Key inclusion criteria (4 listed)
- Patients aged 65 years and older
- Undergoing noncardiac, nonneurosurgical major surgery under general anesthesia
- Monitored postoperatively in the intensive care unit
- Provided informed consent to participate in the study
Key exclusion criteria (7 listed)
- Cardiac or neurosurgical procedures
- Patients younger than 65 years
- Glasgow Coma Scale < 8
- No informed consent
- Body mass index (BMI) > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in neurocognitive function score (Mini-Mental State Examination,MMSE)
Time frame: Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperatively
Between-group difference in the change of Mini-Mental State Examination (MMSE) total score from baseline to 72 hours after surgery, comparing target-controlled infusion (TCI) versus manual infusion. The MMSE is a widely used cognitive screening tool with a total score range of 0 to 30, where higher scores indicate better cognitive function.
2 secondary outcomes
Total sedative and analgesic drug consumption
Time frame: From admission to the intensive care unit (ICU) until completion of the postoperative sedation period (approximately 0-72 hours postoperatively).
Hospital length of stay
Time frame: From the day of surgery until hospital discharge (up to 40 days).
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 31 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions.
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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, MD principal investigator
İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
Zekeriya Ervatan, MD study chair
İstanbul 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 Postoperative Cognitive Dysfunction (POCD) and Neurocognitive Function, run by Namigar Turgut 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 7 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 31 Dec 2025. 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 in neurocognitive function score (Mini-Mental State Examination,MMSE) (time frame: Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperatively). 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 31 Dec 2025.