"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia." (AECGSKD002)

December 10, 2025 updated by: Aygul Valiyeva, Goztepe Training and Research Hospital
We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these patients. In this study, we aimed to investigate the effects of different anesthesia techniques (general anesthesia/spinal anesthesia) applied in orthopedic cases on patient fluid status (pleth variablity index) and regional cerebral oxygenation (NIRS), and their relationship with cognitive dysfunction.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

60

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)
    • Kadikoy
      • Istanbul, Kadikoy, Turkey (Türkiye), 34744
        • Goztepe training and research 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

Patients undergoing Lower extremity surgery

Description

Inclusion Criteria:

  • Patients over the age of 65
  • Patients with an American Society of Anesthesiologists (ASA) score of II-III
  • Patients with a Mini Mental State Examination (MMSE) score of ≥24 on the first day before surgery

Exclusion Criteria:

  • Patients with coagulation disorders
  • Patients with a history of anticoagulant medication use
  • Patients with advanced organ failure
  • Patients with Alzheimer's disease or advanced dementia
  • Patients with allergies to the medications used in the study
  • Mental Retardation
  • Patients with a wound infection at the site of spinal anesthesia
  • Patients with a history of cerebrovascular hemorrhage
  • Patients who did not consent;

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
General Anesthesia
Spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative period (24th and 48th hours) cognitive dysfunction rate
Time Frame: Up to 48 hours after operation
We will assess postoperative cognitive dysfunction.Cognitive function will be evaluated using the MOCA (Montreal Cognitive Assessment) at 24 and 48 hours after surgery.
Up to 48 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pleth Variability Index (PVI, %) to assess intraoperative fluid status
Time Frame: During Surgery
PVI values will be continuously recorded using non-invasive monitor.
During Surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: Up to 48 hours
Mini Mental State Examination (MMSE) will be recorded as the secondary supportive measure like MOCA.
Up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goztepe Training and Research 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)

August 1, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 27, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AECGSKD002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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