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Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients

NCT ID: NCT07311447

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cognitive Dysfunction (POCD) Neurocognitive Function Sedation and Analgesia Geriatric Patients

Keywords

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Target-Controlled Infusion (TCI) Manual Infusion Geriatric Patients Mini-Mental State Examination (MMSE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Namigar Turgut

OTHER

Sponsor Role lead

Responsible Party

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Namigar Turgut

Professor of Anesthesiology and Intensive Care

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Namigar Turgut, MD

Role: PRINCIPAL_INVESTIGATOR

İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

Zekeriya Ervatan, MD

Role: STUDY_CHAIR

İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

Locations

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İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Tascıoglu-TCI-POCD-2025

Identifier Type: -

Identifier Source: org_study_id