An interventional study of BIS-guided light-depth anesthesia management (BIS target 50-65) and BIS-guided deep-depth anesthesia management (BIS target 35-50) in Total Knee Arthroplasty and Postoperative Recovery, sponsored by General Hospital of Ningxia Medical University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Other
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.
General Hospital of Ningxia Medical University is the lead sponsor of 110 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients receive BIS-guided deep-depth anesthesia with target BIS 35-50 during total knee arthroplasty
Device: BIS-guided deep-depth anesthesia management (BIS target 35-50)
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.
Procedure: 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.
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.
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.
Time frame: postoperative day 1
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.
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
Intraoperative awareness will be screened using the Brice interview questionnaire
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)
Postoperative delirium will be screened using the Confusion Assessment Method (CAM). CAM is a validated tool to identify delirium.
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
Hospital length of stay is calculated by reviewing electronic medical records
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
Visual Analog Scale (VAS) for resting pain. Score ranges from 0 to 10. Higher scores indicate more severe pain.
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
Postoperative nausea and vomiting events are identified through clinical bedside observation and review of electronic medical records.
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
Visual Analog Scale (VAS) for activity-induced pain. Score ranges from 0 to 10. Higher scores indicate more severe pain.
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
Richard-Campbell Sleep Questionnaire (RCSQ). Total score ranges from 0 to 100. Higher scores indicate better sleep quality.
Time frame: At pre-operation, postoperative day 1 and postoperative day 3, assessed up to 30 days after randomization.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Nov 2026, 2 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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