Total Knee Replacement SurgeryNCT06241859
The Impact of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After Major Joints Arthroplasty
A study testing Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) in people with Total Knee Replacement Surgery, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 to 90 years
- Conditions the study is for
- Total Knee Replacement Surgery
- What is being tested?
- Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 10 Feb 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences Kaunas Clinics, Department of Anesthesiology
Kaunas
About this study
Official title: The Influence of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After the Elective Total Knee Joints Replacement Surgery in Elderly Patients: Prospective, Randomized, Double-blind Study
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.
Read the detailed description
The aim: To determine value of sedation depth monitoring in order to save patients cognitive functions, to reduce incidence of postoperative delirium and to improve quality of early rehabilitation after the elective total elective knee replacement surgery.
Primary hypothesis: targeted sedation depth monitoring, in order to support light sedation level during the elective knee arthroplasty, helps to save cognitive function and reduce incident of postoperative delirium.
Secondary hypothesis: targeted sedation depth monitoring, in order to support light sedation level, provide better ability to early rehabilitation and patients more quickly return to the rhythm of ordinary life after elective total knee arthroplasty.
Objectives:
- To evaluate moderate and deep sedation rates in a group of patients sedated according to clinical signs only.
- To compare changes in cognitive functions and incidence of delirium after the surgery between a group of patients with light sedation according to bispectral index (BIS) and a group of patients sedated according to clinical signs.
- To assess the impact of sedation depth monitoring for ability and quality of early rehabilitation after elective total knee replacement surgery.
Methods:
The prospective, randomized, double-blinded study includes American Society of Anesthesiologists (ASA) physical status I-II patients in preoperative assessment, aged >65 years, admitted for the elective total knee arthroplasty under spinal anesthesia with sedation. Preoperatively patients will be blindly randomized into one of two groups. Experimental group: light sedation according to BIS and control group: sedation according to clinical signs. Group assignment will be concealed by opaque envelopes that will be opened only after enrolment. The investigator, who does not interview patients, will document which group the participant belongs to and will provide an unique number. The same investigator will collect data in an operating room. But the participant and outcomes assessor will be blinded to group assignment.
During the perioperative period all patients from both groups will receive a standardized anesthetic and analgesic. Premedication of midazolam 2.5 mg will be given to all patients and a slow fluid infusion of crystalloids will be started once as an intravenous cannula will be placed. Spinal anesthesia after identification of the subarachnoid space will be performed with 15 mg of levobupivacaine. After that, for post operative analgesia femoral triangle and adductor canal blocks will be performed under the ultrasound guidance. Patients will be sedated with intravenously administered propofol according to BIS, in order to support light sedation level (BIS value 80-90), or according to clinical sign (depending on the group of patients) during the surgery. During the surgery BIS and standard monitoring will be performed in both groups. After the surgery patients will be transferred to the post-anesthesia care unit (PACU). During the postoperative period NSAIDs and acetaminophen will be available in both groups.
Patients cognitive function will be evaluated before the surgery and at 2, 30, 90 postoperative days using Addenbrooke's Cognitive Examination test - revised (ACE-R). This is 100-scores test that allows to assess the main six cognitive function domains and weighted as follows: orientation (10), attention (8), memory (26), verbal fluency (14), language (26) and visuospatial ability (16).
The ability and quality of rehabilitation will be assessed before the surgery and at 2, 30, 90 days after the surgery using Quality of Life Questionnaire (SF-36v2 Health Survey). This test allows to assess the main eight quality of life domains: vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical and emotional health, social rule functioning, mental health.
Patients emotional state will be evaluated using the Geriatric Depression Scale before the surgery and at 2, 30, 90 postoperative days.
- Conditions
- Total Knee Replacement Surgery
- Being tested
- Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)
- Keywords
- Sedation depth, Cognitive functions, Quality of rehabilitation, Functional recovery, Elective surgery, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 monitor sedation depth.
| Study group | Role | What they receive |
|---|---|---|
| Light sedation according to BIS | Active comparator | Sedation depth will be monitored according to BIS. Receives: 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. Receives: Device: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive function using Addenbrooke's Cognitive Examination test
Measured: 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)
Measured: 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
Measured: During the surgery
Changes in emotional state according to geriatric depression scale
Measured: Before the surgery and first 3 months after elective total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start10 Feb 2024
- Primary completionApr 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inna Jaremko, MD, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241859
- Sponsor's protocol ID
- BE-2-53
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jaremko I, Milkintaite G, Gelmanas A, Smailys A, Lenkutis T, Macas A. The effect of bispectral index-controlled sedation on postoperative cognitive health in elderly patients with spinal anesthesia undergoing elective total knee arthroplasty: randomized, blinded study. J Anesth Analg Crit Care. 2026 Jul 23;6(1):132. doi: 10.1186/s44158-026-00437-0.
PubMed 42897692
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After the Elective Total Knee Joints Replacement Surgery in Elderly Patients: Prospective, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT06241859
- Acronym / sponsor ID
- BE-2-53
- Conditions
- Total Knee Replacement Surgery
- Keywords
- Sedation depth, Cognitive functions, Quality of rehabilitation, Functional recovery, Elective surgery, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim: To determine value of sedation depth monitoring in order to save patients cognitive functions, to reduce incidence of postoperative delirium and to improve quality of early rehabilitation after the elective total elective knee replacement surgery.
Primary hypothesis: targeted sedation depth monitoring, in order to support light sedation level during the elective knee arthroplasty, helps to save cognitive function and reduce incident of postoperative delirium.
Secondary hypothesis: targeted sedation depth monitoring, in order to support light sedation level, provide better ability to early rehabilitation and patients more quickly return to the rhythm of ordinary life after elective total knee arthroplasty.
Objectives:
- To evaluate moderate and deep sedation rates in a group of patients sedated according to clinical signs only.
- To compare changes in cognitive functions and incidence of delirium after the surgery between a group of patients with light sedation according to bispectral index (BIS) and a group of patients sedated according to clinical signs.
- To assess the impact of sedation depth monitoring for ability and quality of early rehabilitation after elective total knee replacement surgery.
Methods:
The prospective, randomized, double-blinded study includes American Society of Anesthesiologists (ASA) physical status I-II patients in preoperative assessment, aged >65 years, admitted for the elective total knee arthroplasty under spinal anesthesia with sedation. Preoperatively patients will be blindly randomized into one of two groups. Experimental group: light sedation according to BIS and control group: sedation according to clinical signs. Group assignment will be concealed by opaque envelopes that will be opened only after enrolment. The investigator, who does not interview patients, will document which group the participant belongs to and will provide an unique number. The same investigator will collect data in an operating room. But the participant and outcomes assessor will be blinded to group assignment.
During the perioperative period all patients from both groups will receive a standardized anesthetic and analgesic. Premedication of midazolam 2.5 mg will be given to all patients and a slow fluid infusion of crystalloids will be started once as an intravenous cannula will be placed. Spinal anesthesia after identification of the subarachnoid space will be performed with 15 mg of levobupivacaine. After that, for post operative analgesia femoral triangle and adductor canal blocks will be performed under the ultrasound guidance. Patients will be sedated with intravenously administered propofol according to BIS, in order to support light sedation level (BIS value 80-90), or according to clinical sign (depending on the group of patients) during the surgery. During the surgery BIS and standard monitoring will be performed in both groups. After the surgery patients will be transferred to the post-anesthesia care unit (PACU). During the postoperative period NSAIDs and acetaminophen will be available in both groups.
Patients cognitive function will be evaluated before the surgery and at 2, 30, 90 postoperative days using Addenbrooke's Cognitive Examination test - revised (ACE-R). This is 100-scores test that allows to assess the main six cognitive function domains and weighted as follows: orientation (10), attention (8), memory (26), verbal fluency (14), language (26) and visuospatial ability (16).
The ability and quality of rehabilitation will be assessed before the surgery and at 2, 30, 90 days after the surgery using Quality of Life Questionnaire (SF-36v2 Health Survey). This test allows to assess the main eight quality of life domains: vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical and emotional health, social rule functioning, mental health.
Patients emotional state will be evaluated using the Geriatric Depression Scale before the surgery and at 2, 30, 90 postoperative days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light sedation according to BIS | Active comparator | Device: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)Sedation depth will be monitored according to BIS. |
| Sedation according to clinical signs | Sham comparator | Device: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)Sedation depth will be monitored according to clinical signs using RASS scale, which aim is -3. |
Who may qualify
- Ages
- 66 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)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. | Device | Light sedation according to BIS |
| Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland)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 monitor sedation depth. | Device | Sedation according to clinical signs |
Primary outcome
Changes in cognitive function using Addenbrooke's Cognitive Examination test
Time frame: Before the surgery and first 3 months after elective total knee arthroplasty
3 secondary outcomes
Quality of functional recovery using the Quality of Life Questionnaire (SF-36v2 Health Survey)
Time frame: 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
Time frame: During the surgery
Changes in emotional state according to geriatric depression scale
Time frame: Before the surgery and first 3 months after elective total knee arthroplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 42897692Jaremko I, Milkintaite G, Gelmanas A, Smailys A, Lenkutis T, Macas A. The effect of bispectral index-controlled sedation on postoperative cognitive health in elderly patients with spinal anesthesia undergoing elective total knee arthroplasty: randomized, blinded study. J Anesth Analg Crit Care. 2026 Jul 23;6(1):132. doi: 10.1186/s44158-026-00437-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) in people with Total Knee Replacement Surgery, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive function using Addenbrooke's Cognitive Examination test (time frame: Before the surgery and first 3 months after elective total knee arthroplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.