Knee InjuriesPhase 4NCT07838948
Nalbuphine With Remimazolam Versus Nalbuphine With Propofol for Knee Arthroscopy
A Phase 4 study testing Nalbuphine, Remimazolam and Propofol in people with Knee Injuries, run by Wuhan Fourth Hospital at 1 site in China.
Trial summary
This study compared two combinations of medicines used for sedation and pain relief in adults undergoing knee arthroscopy for knee joint injuries. One group received nalbuphine with remimazolam, and the other received nalbuphine with propofol. The study examined pain, sedation, cognitive function, and adverse events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Nalbuphine, Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 2 Oct 2025
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee joint injury diagnosed by clinical and imaging examinations, with planned knee arthroscopy.
- Age 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Normal preoperative cognitive function, with Mini-Mental State Examination (MMSE) score >=24.
- No long-term preoperative use of analgesic, sedative, or antipsychotic medication.
Who cannot join
- Psychiatric disorders, including depression, anxiety, or schizophrenia, or neurological disorders, including Parkinson disease, epilepsy, or post-stroke sequelae.
- Allergy to nalbuphine, remimazolam, or related medications.
- Severe hepatic or renal impairment, including cirrhosis or chronic renal failure, or uncontrolled hypertension or diabetes mellitus.
- Considered unsuitable for participation by the investigators.
- Serious intraoperative complications, including anesthesia accidents or massive intraoperative bleeding, or withdrawal during the study (post-enrollment exclusion or withdrawal criteria).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Subanesthetic Doses of Nalbuphine Combined With Remimazolam in Patients Undergoing Arthroscopic Knee Surgery for Knee Joint Injuries
This study compared two combinations of medicines used for sedation and pain relief in adults undergoing knee arthroscopy for knee joint injuries. One group received nalbuphine with remimazolam, and the other received nalbuphine with propofol. The study examined pain, sedation, cognitive function, and adverse events. A total of 100 adults aged 18 to 65 years were randomly assigned to the two groups, with 50 participants in each group. All participants underwent surgery under combined spinal-epidural anesthesia. Pain, sedation, and cognitive function were assessed immediately after surgery and at 6, 12, and 24 hours after surgery.
Read the detailed description
This single-center, randomized, parallel-group study was conducted at Wuhan Fourth Hospital. Participants were assigned using a random-number table. Both groups were managed by the same anesthesia team. Intraoperative assessments included blood pressure, heart rate, respiratory rate, oxygen saturation, anesthesia induction time, anesthesia duration, and awakening time. Postoperative assessments included the Visual Analog Scale for pain, the Ramsay Sedation Scale, and the Mini-Mental State Examination. Adverse events assessed included hypotension, respiratory depression, bradycardia, postoperative agitation, nausea and vomiting, pruritus, chills, and diplopia. The study was approved by the Wuhan Fourth Hospital ethics committee, and participants provided written informed consent before surgery.
No primary outcome measure was prespecified before the study began. This registration is being prepared after study completion.
- Conditions
- Knee Injuries
- Being tested
- Nalbuphine, Remimazolam, Propofol
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Nalbuphine 0.1 mg/kg was administered intravenously at induction in both study groups.
RemimazolamDrug
Remimazolam 0.2-0.3 mg/kg was administered intravenously at induction in the experimental group. If body movement occurred during the procedure, an additional intravenous dose of 0.05 mg/kg was administered as needed until completion.
PropofolDrug
Propofol 1.5-2.0 mg/kg was administered intravenously at induction in the active comparator group. If body movement occurred during the procedure, an additional intravenous dose of 0.5 mg/kg was administered as needed until completion.
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine With Remimazolam | Experimental | 50 participants received nalbuphine 0.1 mg/kg and remimazolam 0.2-0.3 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of remimazolam 0.05 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia. Receives: Drug: Nalbuphine; Drug: Remimazolam |
| Nalbuphine With Propofol | Active comparator | 50 participants received nalbuphine 0.1 mg/kg and propofol 1.5-2.0 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of propofol 0.5 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia. Receives: Drug: Nalbuphine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured by the Visual Analog Scale (retrospectively designated)
Postoperative pain intensity assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Lower scores indicate less pain. Scores are compared between the two treatment groups at each specified assessment. No primary outcome was prespecified before the study began. This measure is designated as primary for this retrospective registration after study completion; it was not a prospectively specified primary endpoint.
Measured: Immediately after surgery and at 6, 12, and 24 hours after surgery
Secondary outcomes (16)
Postoperative sedation measured by the Ramsay Sedation Scale
Sedation assessed with the Ramsay Sedation Scale, ranging from 1 to 6. Higher scores indicate deeper sedation. Scores are compared between the treatment groups at each assessment. Outcome classification is assigned for this retrospective registration; no primary outcome hierarchy was prespecified before study initiation.
Measured: Immediately after surgery and at 6, 12, and 24 hours after surgery
Postoperative Mini-Mental State Examination score
Cognitive performance assessed using the Mini-Mental State Examination (MMSE), with scores ranging from 0 to 30. Higher scores indicate better performance. Scores are compared between the treatment groups at each assessment. Outcome classification is assigned for this retrospective registration; no primary outcome hierarchy was prespecified before study initiation.
Measured: Immediately after surgery and at 6, 12, and 24 hours after surgery
Incidence of postoperative agitation
Percentage of participants with postoperative agitation recorded during postoperative observation. The manuscript does not specify a grading scale or severity threshold. Classification as a secondary outcome is assigned for retrospective registration.
Measured: From the end of surgery through 24 hours after surgery
Incidence of postoperative nausea and vomiting
Percentage of participants with postoperative nausea and vomiting recorded during postoperative observation. Classification as a secondary outcome is assigned for retrospective registration.
Measured: From the end of surgery through 24 hours after surgery
Incidence of intraoperative hypotension
Percentage of participants with systolic blood pressure below 90 mmHg or a decrease greater than 20% from baseline during surgery. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Incidence of intraoperative respiratory depression
Percentage of participants with oxygen saturation below 90% or respiratory rate below 8 breaths per minute during surgery. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Incidence of bradycardia
Percentage of participants with heart rate below 50 beats per minute. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During the perioperative observation period, through 24 hours after surgery
Incidence of pruritus, chills, and diplopia
The percentage of participants experiencing each of the following events is assessed separately: pruritus, chills, and diplopia. This is not a composite endpoint. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During the perioperative observation period, through 24 hours after surgery
Intraoperative blood pressure
Systolic, diastolic, and mean arterial pressure measured in mmHg during surgery are compared separately between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Intraoperative heart rate
Heart rate measured in beats per minute during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Intraoperative respiratory rate
Respiratory rate measured in breaths per minute during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Intraoperative oxygen saturation
Peripheral oxygen saturation (SpO2), expressed as a percentage, recorded during surgery and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During surgery
Anesthesia induction time
Time required for anesthesia induction, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During anesthesia induction on the day of surgery
Duration of anesthesia
Duration of anesthesia, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During anesthesia on the day of surgery
Awakening time
Time to awakening after anesthesia, recorded in minutes and compared between treatment groups. Classification as a secondary outcome is assigned for retrospective registration.
Measured: During recovery from anesthesia on the day of surgery
Postoperative cognitive impairment based on the manuscript MMSE threshold
Percentage of participants with a Mini-Mental State Examination score of 24 or less, the threshold described in the manuscript as suggesting cognitive dysfunction. MMSE scores range from 0 to 30, with higher scores indicating better performance. Classification as a secondary outcome is assigned for retrospective registration.
Measured: Immediately after surgery and at 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start10 Apr 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned in a 1:1 ratio using a random-number table to nalbuphine with remimazolam or nalbuphine with propofol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Zhou, Wuhan Fourth Hospital
- Investigators
- Zhang Zhou, Principal investigator, Wuhan Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838948
- Sponsor's protocol ID
- KY2025-073-02
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Subanesthetic Doses of Nalbuphine Combined With Remimazolam in Patients Undergoing Arthroscopic Knee Surgery for Knee Joint Injuries
- ClinicalTrials.gov ID
- NCT07838948
- Acronym / sponsor ID
- KY2025-073-02
- Conditions
- Knee Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wuhan Fourth HospitalUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 24 Sep 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 study compared two combinations of medicines used for sedation and pain relief in adults undergoing knee arthroscopy for knee joint injuries. One group received nalbuphine with remimazolam, and the other received nalbuphine with propofol. The study examined pain, sedation, cognitive function, and adverse events. A total of 100 adults aged 18 to 65 years were randomly assigned to the two groups, with 50 participants in each group. All participants underwent surgery under combined spinal-epidural anesthesia. Pain, sedation, and cognitive function were assessed immediately after surgery and at 6, 12, and 24 hours after surgery.
Detailed description
This single-center, randomized, parallel-group study was conducted at Wuhan Fourth Hospital. Participants were assigned using a random-number table. Both groups were managed by the same anesthesia team. Intraoperative assessments included blood pressure, heart rate, respiratory rate, oxygen saturation, anesthesia induction time, anesthesia duration, and awakening time. Postoperative assessments included the Visual Analog Scale for pain, the Ramsay Sedation Scale, and the Mini-Mental State Examination. Adverse events assessed included hypotension, respiratory depression, bradycardia, postoperative agitation, nausea and vomiting, pruritus, chills, and diplopia. The study was approved by the Wuhan Fourth Hospital ethics committee, and participants provided written informed consent before surgery.
No primary outcome measure was prespecified before the study began. This registration is being prepared after study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned in a 1:1 ratio using a random-number table to nalbuphine with remimazolam or nalbuphine with propofol.
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine With Remimazolam | Experimental | Drug: Nalbuphine, Drug: Remimazolam50 participants received nalbuphine 0.1 mg/kg and remimazolam 0.2-0.3 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of remimazolam 0.05 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia. |
| Nalbuphine With Propofol | Active comparator | Drug: Nalbuphine, Drug: Propofol50 participants received nalbuphine 0.1 mg/kg and propofol 1.5-2.0 mg/kg intravenously at induction. If body movement occurred during the procedure, an additional intravenous dose of propofol 0.5 mg/kg was administered as needed until completion. Knee arthroscopy was performed under combined spinal-epidural anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Knee joint injury diagnosed by clinical and imaging examinations, with planned knee arthroscopy.
- Age 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Normal preoperative cognitive function, with Mini-Mental State Examination (MMSE) score >=24.
- No long-term preoperative use of analgesic, sedative, or antipsychotic medication.
Key exclusion criteria (5 listed)
- Psychiatric disorders, including depression, anxiety, or schizophrenia, or neurological disorders, including Parkinson disease, epilepsy, or post-stroke sequelae.
- Allergy to nalbuphine, remimazolam, or related medications.
- Severe hepatic or renal impairment, including cirrhosis or chronic renal failure, or uncontrolled hypertension or diabetes mellitus.
- Considered unsuitable for participation by the investigators.
- Serious intraoperative complications, including anesthesia accidents or massive intraoperative bleeding, or withdrawal during the study (post-enrollment exclusion or withdrawal criteria).
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 |
|---|---|---|
| NalbuphineNalbuphine 0.1 mg/kg was administered intravenously at induction in both study groups. | Drug | Nalbuphine With Propofol, Nalbuphine With Remimazolam |
| RemimazolamRemimazolam 0.2-0.3 mg/kg was administered intravenously at induction in the experimental group. If body movement occurred during the procedure, an additional intravenous dose of 0.05 mg/kg was administered as needed until completion. | Drug | Nalbuphine With Remimazolam |
| PropofolPropofol 1.5-2.0 mg/kg was administered intravenously at induction in the active comparator group. If body movement occurred during the procedure, an additional intravenous dose of 0.5 mg/kg was administered as needed until completion. | Drug | Nalbuphine With Propofol |
Primary outcome
Postoperative pain measured by the Visual Analog Scale (retrospectively designated)
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
Postoperative pain intensity assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Lower scores indicate less pain. Scores are compared between the two treatment groups at each specified assessment. No primary outcome was prespecified before the study began. This measure is designated as primary for this retrospective registration after study completion; it was not a prospectively specified primary endpoint.
16 secondary outcomes
Postoperative sedation measured by the Ramsay Sedation Scale
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
Postoperative Mini-Mental State Examination score
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
Incidence of postoperative agitation
Time frame: From the end of surgery through 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: From the end of surgery through 24 hours after surgery
Incidence of intraoperative hypotension
Time frame: During surgery
Incidence of intraoperative respiratory depression
Time frame: During surgery
Incidence of bradycardia
Time frame: During the perioperative observation period, through 24 hours after surgery
Incidence of pruritus, chills, and diplopia
Time frame: During the perioperative observation period, through 24 hours after surgery
Intraoperative blood pressure
Time frame: During surgery
Intraoperative heart rate
Time frame: During surgery
Intraoperative respiratory rate
Time frame: During surgery
Intraoperative oxygen saturation
Time frame: During surgery
Anesthesia induction time
Time frame: During anesthesia induction on the day of surgery
Duration of anesthesia
Time frame: During anesthesia on the day of surgery
Awakening time
Time frame: During recovery from anesthesia on the day of surgery
Postoperative cognitive impairment based on the manuscript MMSE threshold
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Zhang Zhou principal investigator
Wuhan Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine, Remimazolam and Propofol in people with Knee Injuries, run by Wuhan Fourth Hospital 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 5 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: finished, as of the sponsor's last update on 24 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain measured by the Visual Analog Scale (retrospectively designated) (time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery). 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 24 Sep 2026.