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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07302061

Acronym

AECGSKD002

Enrollment

Registered

2025-12-24

Start date

2025-08-01

Completion date

2027-06-01

Last updated

2026-09-17

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

Conditions

Postoperative Cognitive Deficit (POCD)

Keywords

POCD

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Early postoperative period (24th and 48th hours) cognitive dysfunction rate	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.

Secondary

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

Countries

Turkey (Türkiye)

Outcome results