The Impact of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After Ma… (NCT06241859) | Clinical Trial Compass
UnknownNot Applicable
The Impact of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After Major Joints Arthroplasty
Lithuania100 participantsStarted 2024-02-10
Plain-language summary
Spinal anesthesia is applied for patients undergoing total elective knee replacement surgery. It reduces rates of postoperative complications, improves postoperative pain management, rehabilitation is started earlier and patients more quickly return to the rhythm of ordinary life. According to the literature data, perioperative stress impacts part of cardiovascular complications and exacerbates postoperative pain. It is important that patients during the surgery under spinal anesthesia prefer to sleep. Thus, in order to reduce perioperative stress, patients during surgery are sedated. It is one of the most effective methods.
On the other hand, deep sedation during surgery versus light sedation, is related to more frequent postoperative cognitive impairment and delirium. It leads to worse later surgery results and worse postoperative quality of life, increased risk of falling, prolonged duration of hospitalization, increased expenses.
Who can participate
Age range
66 Years – 90 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 undergoing elective total knee replacement surgery under spinal anesthesia with sedation;
* Age 66 - 90 years;
* Patients conformed to American Society of Anesthesiologists (ASA) physical status I-II in preoperative assessment;
* Ability to follow study protocol;
* Signed agreement to participate in the study.
Exclusion Criteria:
* Refused elective total knee arthroplasty under spinal anesthesia with sedation;
* Younger than 66 years;
* Patients conformed to American Society of Anesthesiologists (ASA) physical status III-IV in preoperative assessment;
* Patients with mental and central nervous system disorders, which hinder the perception and correct assessment of their condition;
* Hearing, visual, speech disorders and inability to read, write;
* Inability to understand and read in Lithuanian language;
* Refusal to participate in the study.
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
Changes in cognitive function using Addenbrooke's Cognitive Examination test
Timeframe: Before the surgery and first 3 months after elective total knee arthroplasty