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Completed
NCT07838948
Nalbuphine With Remimazolam Versus Nalbuphine With Propofol for Knee Arthroscopy
Conditions: Knee Injuries
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: Wuhan Fourth Hospital
Location: Wuhan Fourth Hospital Wuhan Hubei
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Source: ClinicalTrials.gov (NCT07838948). StuddyBuddy aggregates publicly available trial information.