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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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

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
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

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

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

Namigar Turgut

Investigators

  • 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)

May 5, 2025

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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