The Impact of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After Major Joints Arthroplasty

Launched by LITHUANIAN UNIVERSITY OF HEALTH SCIENCES · Jan 28, 2024

Keywords

ClinConnect Summary

This ongoing study asks whether using a brain-monitoring device (BIS) to keep sedation light during elective knee replacement surgery (under spinal anesthesia) helps protect thinking skills, reduces delirium after surgery, and supports faster, better early recovery and quality of life. In this randomized, double-blind trial, participants are assigned to either BIS-guided light sedation (target BIS 80-90) or sedation based on clinical signs alone (RASS around -3). The main question is whether the BIS-guided approach preserves cognitive function, measured with the ACE-R test before surgery and up to 3 months after. Secondary questions include mood, overall quality of life, and how deeply patients are sedated during surgery.

Eligible participants are adults aged 66–90 undergoing elective knee replacement with spinal anesthesia who are ASA I–II, can read Lithuanian, and can follow the study procedures. They will be randomly assigned to one of the two groups, with both patients and those assessing outcomes blinded to group assignment. All will receive standard anesthesia and pain relief, and assessments will occur before surgery and at 2, 30, and 90 days after surgery. The study is being conducted in Kaunas, Lithuania, at the Lithuanian University of Health Sciences, and is currently enrolling about 100 participants; results are not yet available.

Gender

ALL

Eligibility criteria

• 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.