Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients (TCI-NEURO)

December 21, 2025 updated by: Namigar Turgut

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.

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.

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.
50

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 (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Istanbul 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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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.
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 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 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.
Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperatively

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
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).
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.
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).
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.
From the day of surgery until hospital discharge (up to 40 days).

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.
Namigar Turgut

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, MD, Istanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
  • Study Chair: Zekeriya Ervatan, MD, Istanbul 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 5, 2025

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.
October 31, 2025

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.
October 31, 2025

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).
December 8, 2025

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.
December 21, 2025

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.
December 31, 2025

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.
December 31, 2025

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.
December 21, 2025

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.
December 1, 2025

More Information

Terms related to this study

Keywords

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.
  • Tascıoglu-TCI-POCD-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional and ethical restrictions.

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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