Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients

NCT07311447 | Completed

• 1 other identifier: Tascıoglu-TCI-POCD-2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Total sedative and analgesic drug consumption

  From admission to the intensive care unit (ICU) until completion of the postoperative sedation period (approximately 0-72 hours postoperatively).

• Hospital length of stay

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namigar Turgut: lead

Study Sites (1)

İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Namigar Turgut, MD

  İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

  PRINCIPAL INVESTIGATOR

• Zekeriya Ervatan, MD

  İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 31, 2025
• Study Start: May 5, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)