A Phase 4 interventional study of Nalbuphine and Remimazolam in Knee Injuries, sponsored by Wuhan Fourth Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Wuhan Fourth Hospital · Phase 4, Interventional, and Supportive care
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.
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.
267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.
This study's enrollment of 100 is above the median of 49 across 178 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →This is the only study on the registry with Wuhan Fourth Hospital as lead sponsor.
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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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Nalbuphine · Drug: Remimazolam
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.
Drug: Nalbuphine · Drug: Propofol
Nalbuphine 0.1 mg/kg was administered intravenously at induction in both study groups.
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.
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.
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.
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after surgery and at 6, 12, and 24 hours after surgery
Ran from Apr 2025 to primary completion in Oct 2025, 5 months.
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Studies of the drug tested here: Remimazolam