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

NCT07302061 | Active Not Recruiting

• 1 other identifier: AECGSKD002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Deficit (POCD)

Keywords

POCD

Outcome Measures

Primary Outcomes (1)

• Early postoperative period (24th and 48th hours) cognitive dysfunction rate

  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 Outcomes (1)

• Pleth Variability Index (PVI, %) to assess intraoperative fluid status

  During Surgery

Other Outcomes (1)

• Mini Mental State Examination (MMSE)

  Up to 48 hours

Study Arms (2)

General Anesthesia

Spinal anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Lower extremity surgery

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

Goztepe training and research hospital

Istanbul, Kadikoy, 34744, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 24, 2025
• Study Start: August 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

TU (1)