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

NCT ID: NCT07302061

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cognitive Deficit (POCD)

Keywords

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POCD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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General Anesthesia

No interventions assigned to this group

Spinal anesthesia

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goztepe Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aygul Valiyeva

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Goztepe training and research hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AECGSKD002

Identifier Type: -

Identifier Source: org_study_id