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Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients

The Effect of Target-Controlled Infusion (TCI) on Neurocognitive Functions in Postoperative Sedoanalgesia Management in Geriatric Patients Undergoing Major Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07311447
Acronym
TCI-NEURO
Enrollment
50
Registered
2025-12-31
Start date
2025-05-05
Completion date
2025-10-31
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

Namigar Turgut
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in neurocognitive function score (Mini-Mental State Examination,MMSE)Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperativelyBetween-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.

Secondary

MeasureTime frameDescription
Total sedative and analgesic drug consumptionFrom 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.
Hospital length of stayFrom 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026