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NCT Number: NCT07302061

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Postoperative Cognitive Deficit (POCD)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goztepe training and research hospital

Istanbul, Kadikoy, 34744, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: During Surgery

    PVI values will be continuously recorded using non-invasive monitor.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Goztepe Training and Research Hospital

Other

Registry information

Acronym: AECGSKD002

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 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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