Nalbuphine With Remimazolam Versus Nalbuphine With Propofol for Knee Arthroscopy

NCT07838948 | Completed Phase 4

• 1 other identifier: KY2025-073-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after surgery and at 6, 12, and 24 hours after surgery

Secondary Outcomes (16)

• Postoperative sedation measured by the Ramsay Sedation Scale

  Immediately after surgery and at 6, 12, and 24 hours after surgery

• Postoperative Mini-Mental State Examination score

  Immediately after surgery and at 6, 12, and 24 hours after surgery

• Incidence of postoperative agitation

  From the end of surgery through 24 hours after surgery

• Incidence of postoperative nausea and vomiting

  From the end of surgery through 24 hours after surgery

• Incidence of intraoperative hypotension

  During surgery

Study Arms (2)

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.

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.

Drug: Nalbuphine; Drug: Propofol

Interventions

Nalbuphine DRUG

Nalbuphine 0.1 mg/kg was administered intravenously at induction in both study groups.

Nalbuphine With Propofol; Nalbuphine With Remimazolam

Remimazolam DRUG

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.

Nalbuphine With Remimazolam

Propofol DRUG

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.

Nalbuphine With Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Fourth Hospital: lead

Study Sites (1)

Wuhan Fourth Hospital

Wuhan, Hubei, 430035, China

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Nalbuphine; remimazolam; Propofol

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Zhang Zhou

  Wuhan Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain, sedation, and cognitive function scores were assessed by Qian Xu, who was unaware of the assigned drug regimen.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were assigned in a 1:1 ratio using a random-number table to nalbuphine with remimazolam or nalbuphine with propofol.

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 24, 2026
• Study Start: April 10, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

CN (1)