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NCT Number: NCT07311447

Target-Controlled Infusion and Postoperative Neurocognitive Outcomes in Geriatric Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Namigar Turgut

Other

Registry information

Official study title

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

Acronym: TCI-NEURO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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