Total Knee ArthroplastyNCT07906457
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
A study testing BIS-guided light-depth anesthesia management (BIS target 50-65) and BIS-guided deep-depth anesthesia management (BIS target 35-50) in people with Total Knee Arthroplasty and Postoperative Recovery, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
This is a prospective, single-center, randomized, double-blind controlled trial. The purpose of this study is to determine whether depth-controlled anesthesia with ciprofol guided by Bispectral Index (BIS) can improve early postoperative recovery quality in elderly patients undergoing knee replacement surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Recovery
- What is being tested?
- BIS-guided light-depth anesthesia management (BIS target 50-65) and BIS-guided deep-depth anesthesia management (BIS target 35-50)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Aged 60 years or older
- Able to complete questionnaires
- Capable of understanding and signing the informed consent form
Who cannot join
- Patients with a confirmed history of anesthetic drug allergy
- Pre-existing cognitive dysfunction before surgery
- Requirement for concurrent surgeries other than knee arthroplasty
- Patients undergoing bilateral knee arthroplasty, knee revision arthroplasty, or other joint replacement surgeries
- Severe hepatic dysfunction (Child-Pugh class C or higher)
- Long-term regular use of benzodiazepines, antidepressants, antipsychotics or other drugs affecting electroencephalographic activity and anesthetic sensitivity
- Patients with chronic alcohol abuse
- Patients with language communication disorders or inability to cooperate with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective, single-center, randomized, double-blind controlled trial. The purpose of this study is to determine whether depth-controlled anesthesia with ciprofol guided by Bispectral Index (BIS) can improve early postoperative recovery quality in elderly patients undergoing knee replacement surgery. A total of 130 eligible participants aged 60 years or older will be enrolled.
Participants will be randomly assigned to two groups using block randomization based on the Charlson Comorbidity Index (CCI):
Read more
Deep-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 35-50.
Light-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 50-65.
Intraoperative BIS values will be continuously monitored, and ciprofol infusion rates will be adjusted to keep BIS within the target range in each group. Standardized pain management including peripheral nerve blocks and postoperative ultrasound-guided continuous femoral nerve block will be provided for all participants. Blood pressure will be managed following the same protocol in both groups.
The primary outcome is postoperative recovery quality assessed by the Quality of Recovery-15 (QOR-15) questionnaire on the first day after surgery. Investigators will also collect QOR-15 scores on postoperative day 2 and day 3, and record other clinical outcomes including intraoperative hemodynamic events, postoperative delirium, nausea and vomiting, pain level, sleep quality and hospital length of stay. This study aims to compare postoperative recovery between two different BIS-targeted anesthesia depths for older adults receiving joint-replacement surgery.
- Conditions
- Total Knee Arthroplasty, Postoperative Recovery
- Being tested
- BIS-guided light-depth anesthesia management (BIS target 50-65), BIS-guided deep-depth anesthesia management (BIS target 35-50)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-guided light-depth anesthesia management (BIS target 50-65)Procedure or surgery
Intraoperative processed electroencephalography (BIS monitor) is used to guide ciprofol infusion to maintain BIS value within 50-65. All subjects receive standardized general-anesthesia induction, ultrasound-guided continuous femoral nerve block for postoperative analgesia, and uniform hemodynamic management.
BIS-guided deep-depth anesthesia management (BIS target 35-50)Device
Intraoperative processed electroencephalography (BIS monitor) is used to guide ciprofol infusion to maintain BIS value within 35-50. All subjects receive standardized general-anesthesia induction, ultrasound-guided continuous femoral nerve block for postoperative analgesia, and uniform hemodynamic management.
| Study group | Role | What they receive |
|---|---|---|
| deep-depth anesthesia group | Experimental | patients receive BIS-guided deep-depth anesthesia with target BIS 35-50 during total knee arthroplasty Receives: Device: BIS-guided deep-depth anesthesia management (BIS target 35-50) |
| light-depth anesthesia group | Experimental | Subjects receive BIS-guided light-depth anesthesia management with target BIS value 50-65 during total knee arthroplasty. All subjects receive standardized anesthesia induction, ultrasound-guided continuous femoral nerve block and uniform hemodynamic management. Receives: Procedure: BIS-guided light-depth anesthesia management (BIS target 50-65) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery-15 (QOR-15) score
The 15-item Quality of Recovery-15 scale assessing postoperative recovery quality, total score ranges from 0 to 150; higher scores indicate better postoperative recovery quality.
Measured: postoperative day 1
Secondary outcomes (8)
Quality of Recovery-15 (QOR-15) score
The 15-item Quality of Recovery Scale (QoR-15). Total score ranges from 0 to 150. Higher scores indicate better postoperative recovery quality.
Measured: At postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of intraoperative awareness assessed by Brice interview
Intraoperative awareness will be screened using the Brice interview questionnaire
Measured: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Postoperative delirium will be screened using the Confusion Assessment Method (CAM). CAM is a validated tool to identify delirium.
Measured: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Hospital length of stay assessed by medical chart review
Hospital length of stay is calculated by reviewing electronic medical records
Measured: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days after randomization
Visual Analog Scale (VAS)-rest pain score
Visual Analog Scale (VAS) for resting pain. Score ranges from 0 to 10. Higher scores indicate more severe pain.
Measured: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of postoperative nausea and vomiting (PONV) within postoperative 3 days assessed by clinical observation and medical chart review
Postoperative nausea and vomiting events are identified through clinical bedside observation and review of electronic medical records.
Measured: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Visual Analog Scale (VAS)-activity pain score
Visual Analog Scale (VAS) for activity-induced pain. Score ranges from 0 to 10. Higher scores indicate more severe pain.
Measured: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Richard-Campbell Sleep Questionnaire (RCSQ) score
Richard-Campbell Sleep Questionnaire (RCSQ). Total score ranges from 0 to 100. Higher scores indicate better sleep quality.
Measured: At pre-operation, postoperative day 1 and postoperative day 3, assessed up to 30 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906457
- Sponsor's protocol ID
- KYLL-2026-1259
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07906457
- Acronym / sponsor ID
- KYLL-2026-1259
- Conditions
- Total Knee Arthroplasty, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2026 (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.
This is a prospective, single-center, randomized, double-blind controlled trial. The purpose of this study is to determine whether depth-controlled anesthesia with ciprofol guided by Bispectral Index (BIS) can improve early postoperative recovery quality in elderly patients undergoing knee replacement surgery. A total of 130 eligible participants aged 60 years or older will be enrolled.
Participants will be randomly assigned to two groups using block randomization based on the Charlson Comorbidity Index (CCI):
Deep-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 35-50.
Light-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 50-65.
Intraoperative BIS values will be continuously monitored, and ciprofol infusion rates will be adjusted to keep BIS within the target range in each group. Standardized pain management including peripheral nerve blocks and postoperative ultrasound-guided continuous femoral nerve block will be provided for all participants. Blood pressure will be managed following the same protocol in both groups.
The primary outcome is postoperative recovery quality assessed by the Quality of Recovery-15 (QOR-15) questionnaire on the first day after surgery. Investigators will also collect QOR-15 scores on postoperative day 2 and day 3, and record other clinical outcomes including intraoperative hemodynamic events, postoperative delirium, nausea and vomiting, pain level, sleep quality and hospital length of stay. This study aims to compare postoperative recovery between two different BIS-targeted anesthesia depths for older adults receiving joint-replacement surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep-depth anesthesia group | Experimental | Device: BIS-guided deep-depth anesthesia management (BIS target 35-50)patients receive BIS-guided deep-depth anesthesia with target BIS 35-50 during total knee arthroplasty |
| light-depth anesthesia group | Experimental | Procedure: BIS-guided light-depth anesthesia management (BIS target 50-65)Subjects receive BIS-guided light-depth anesthesia management with target BIS value 50-65 during total knee arthroplasty. All subjects receive standardized anesthesia induction, ultrasound-guided continuous femoral nerve block and uniform hemodynamic management. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing elective total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Aged 60 years or older
- Able to complete questionnaires
- Capable of understanding and signing the informed consent form
Key exclusion criteria (8 listed)
- Patients with a confirmed history of anesthetic drug allergy
- Pre-existing cognitive dysfunction before surgery
- Requirement for concurrent surgeries other than knee arthroplasty
- Patients undergoing bilateral knee arthroplasty, knee revision arthroplasty, or other joint replacement surgeries
- Severe hepatic dysfunction (Child-Pugh class C or higher)
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 |
|---|---|---|
| BIS-guided light-depth anesthesia management (BIS target 50-65)Intraoperative processed electroencephalography (BIS monitor) is used to guide ciprofol infusion to maintain BIS value within 50-65. All subjects receive standardized general-anesthesia induction, ultrasound-guided continuous femoral nerve block for postoperative analgesia, and uniform hemodynamic management. | Procedure or surgery | light-depth anesthesia group |
| BIS-guided deep-depth anesthesia management (BIS target 35-50)Intraoperative processed electroencephalography (BIS monitor) is used to guide ciprofol infusion to maintain BIS value within 35-50. All subjects receive standardized general-anesthesia induction, ultrasound-guided continuous femoral nerve block for postoperative analgesia, and uniform hemodynamic management. | Device | deep-depth anesthesia group |
Primary outcome
Postoperative Quality of Recovery-15 (QOR-15) score
Time frame: postoperative day 1
The 15-item Quality of Recovery-15 scale assessing postoperative recovery quality, total score ranges from 0 to 150; higher scores indicate better postoperative recovery quality.
8 secondary outcomes
Quality of Recovery-15 (QOR-15) score
Time frame: At postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of intraoperative awareness assessed by Brice interview
Time frame: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of postoperative delirium assessed by Confusion Assessment Method (CAM)
Time frame: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Hospital length of stay assessed by medical chart review
Time frame: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days after randomization
Visual Analog Scale (VAS)-rest pain score
Time frame: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Incidence of postoperative nausea and vomiting (PONV) within postoperative 3 days assessed by clinical observation and medical chart review
Time frame: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Visual Analog Scale (VAS)-activity pain score
Time frame: At postoperative day 1, postoperative day 2 and postoperative day 3, assessed up to 30 days after randomization.
Richard-Campbell Sleep Questionnaire (RCSQ) score
Time frame: At pre-operation, postoperative day 1 and postoperative day 3, assessed up to 30 days after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-guided light-depth anesthesia management (BIS target 50-65) and BIS-guided deep-depth anesthesia management (BIS target 35-50) in people with Total Knee Arthroplasty and Postoperative Recovery, run by General Hospital of Ningxia Medical University at 1 site in China.
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 8 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xinli ni (18195226033, xinlini@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery-15 (QOR-15) score (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.