"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction… (NCT07302061) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."
Turkey (Türkiye)60 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early postoperative period (24th and 48th hours) cognitive dysfunction rate