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

NCT06241859 | Unknown DMC

• 1 other identifier: BE-2-53
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Replacement Surgery

Keywords

Sedation depth; Cognitive functions; Quality of rehabilitation; Functional recovery; Elective surgery; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive function using Addenbrooke's Cognitive Examination test

  Before the surgery and first 3 months after elective total knee arthroplasty

Secondary Outcomes (3)

• Quality of functional recovery using the Quality of Life Questionnaire (SF-36v2 Health Survey)

  Before the surgery and first 3 months after elective total knee arthroplasty

• Rates of moderate and deep sedation according to the BIS in non-interventional group

  During the surgery

• Changes in emotional state according to geriatric depression scale

  Before the surgery and first 3 months after elective total knee arthroplasty

Study Arms (2)

Light sedation according to BIS

ACTIVE COMPARATOR

Sedation depth will be monitored according to BIS.

Device: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)

Sedation according to clinical signs

SHAM COMPARATOR

Sedation depth will be monitored according to clinical signs using RASS scale, which aim is -3.

Device: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)

Interventions

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) DEVICE

Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) will be used to maintain a sedation depth between 80-90 value, which corresponds to light sedation definition.

Light sedation according to BIS

Eligibility Criteria

• Age: 66 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics, Department of Anesthesiology

Kaunas, Lithuania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 10, 2024
• Primary Completion: April 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-01

Locations

LI (1)