An interventional study of Propofol + Remifentanil +Midazolam and Propofol + Remifentanil + Dexmedetomidine in Knee Osteoarthritis, Replacement, Knee and Elective Surgical Patients, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Prevention
Among 136 studies in Osteoarthritis, Knee with a site in China — 32 open to participants now, 32 under way, 4 of them phase 3. Osteoarthritis, Knee · China.
Among the 136 studies in Osteoarthritis, Knee with a site in China, this one is the 58th largest by planned enrollment of the 115 interventional ones that give a count, is one of 12 that started in 2026, is one of 61 with no phase, reaches primary completion later than 23 of the 31 other live ones, and was the 131st registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
Browse Osteoarthritis, Knee studies →32 of the 136 studies in Osteoarthritis, Knee with a site in China are open now. Recruiting first, the newest first:
Hangzhou Sciwind Biosciences Co., Ltd. · Sites in China
Ages 18–75
The First Affiliated Hospital of Xinxiang Medical College · Sites in China
Ages 18–65
Belief BioMed (Beijing) Co., Ltd · Sites in China
Ages 40–75
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 40–70
Wuxi Cellular Biopharmaceutical Group Ltd. · Sites in China
Ages 40–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
136 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 15 · Phase 3 15 · Phase 4 15
First in 2000; this study’s year is marked. 12 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 100 across the 115 interventional studies, 136 across the 21 observational. Of the 53 that completed or were terminated, 6 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
31 of 136 have an industry lead sponsor. The 10 most frequent:
China-Japan Friendship Hospital is the lead sponsor of 179 studies on the registry; 112 are open to participants now.
China-Japan Friendship Hospital has 1 study filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
9 of the studies in Osteoarthritis, Knee with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06570291Phase 3Wuxi Cellular Biopharmaceutical Group Ltd.Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis | 2026-12 |
| NCT07868224Jiangxi University of Traditional Chinese MedicineValidating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials | 2026-12-01 |
| NCT07504562ShuGuang HospitalKnee Pain Ejiao Paste for Knee Osteoarthritis | 2026-12-31 |
| NCT06010979Tian HuaClinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology | 2026-12-31 |
| NCT07736352China-Japan Friendship HospitalExploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants. | 2027-01-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 136 studies in Osteoarthritis, Knee with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to determine the appropriate Bispectral Index (BIS) range and propofol effect-site concentration required to maintain adequate anesthesia depth during total intravenous anesthesia (TIVA) combined with midazolam, dexmedetomidine, or esketamine in patients undergoing unilateral knee replacement surgery. The main questions it aims to answer are:
Participants will:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Propofol + Remifentanil
Drug: Propofol + Remifentanil +Midazolam
Drug: Propofol + Remifentanil + Dexmedetomidine
Drug: Propofol + Remifentanil + Esketamine
Drug pages: Propofol · Remifentanil · Midazolam
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Midazolam (2 mg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS \> 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
Drug pages: Propofol · Remifentanil · Dexmedetomidine
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Dexmedetomidine 1 μg/kg infused over 10 minutes.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS \> 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
Drug pages: Propofol · Remifentanil · Esketamine
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. Esketamine (0.3 mg/kg) will be administered intravenously.The propofol plasma-site concentration will be set to 1.8 μg/mL, then reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS \> 75 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
Participants in this arm will receive total intravenous anesthesia (TIVA) with propofol and remifentanil during the maintenance period. After placement of the knee prosthesis, the isolated forearm technique (IFT) will be initiated. Participants will wear headphones playing recorded standardized instructions. Rocuronium (0.3 mg/kg) will be administered via the non-dominant arm. The propofol plasma-site concentration will be reduced in stepwise decrements of 0.3 μg/mL, with each concentration maintained for 5 minutes, until any of the following endpoints is reached: (1) positive IFT response , (2) BIS \> 60 sustained for 1 minute, (3) electroencephalogram signs of arousal, or (4) clinical judgment by the anesthesiologist that anesthesia depth is inadequate.
BIS value
BIS value recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
Time frame: From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
Propofol Effect-Site Concentration
Propofol effect-site concentration recorded at the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia.
Time frame: From the start of the intra-operative stepwise reduction phase until the first occurrence of IFT positivity or any predefined clinical sign of inadequate anesthesia, assessed up to 30 minutes.
Modified Brice Questionnaire
The presence of intra-operative awareness with recall is assessed using the Modified Brice Questionnaire. The questionnaire explores the patient's memory of the peri-operative period through structured questions.
Time frame: From PACU admission to 48 hours postoperatively. Assessed before PACU discharge, 24 hours and 48 hours postoperatively.
Time from Discontinuation of Anesthetics to Laryngeal Mask Airway Removal
From discontinuation of anesthetics to LMA removal. Successful removal is defined as the patient being awake, able to open mouth on command, and having return of protective reflexes, without signs of respiratory distress.
Time frame: From discontinuation of anesthetics to LMA removal, assessed up to 60 minutes.
Time to Modified Aldrete Score of 10 in the Post Anesthesia Care Unit
Time from post anesthesia care unit (PACU) admission until the first attainment of a Modified Aldrete Score of 10. The Modified Aldrete Score assesses five domains: consciousness, activity, respiration, blood pressure, and oxygen saturation, each scored from 0 to 2, with a maximum total score of 10. A score of 10 indicates the patient has achieved optimal recovery in all five domains.
Time frame: From PACU admission to Modified Aldrete Score of 10, assessed up to 60 minutes.
Adverse Events During Emergence from Anesthesia
Adverse events during the period from anesthetic discontinuation to PACU discharge are recorded.
Time frame: From discontinuation of anesthetics to PACU discharge, assessed up to 2 hours.
Postoperative Pain Intensity Measured by Numeric Rating Scale
Pain intensity is assessed using the Numeric Rating Scale, an 11-point scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain". Patients are asked to rate their current pain intensity at each assessment time point. The Numeric Rating Scale is a widely used and validated measure for postoperative pain assessment.
Time frame: From PACU admission to 48 hours postoperatively. Assessed at PACU admission, PACU discharge, 24 hours and 48 hours postoperatively.
Analgesic Consumption
Total amount of rescue analgesic medication administered to the patient from PACU admission to 48 hours postoperatively.
Time frame: From PACU admission to 48 hours postoperatively. Recorded during PACU stay, 24 hours and 48 hours postoperatively.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 6 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jul 2026, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 ↗
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Studies of the drugs tested here: Propofol · Remifentanil · Midazolam · Dexmedetomidine · Esketamine
China-Japan Friendship Hospital →