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Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery

Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery

Recruiting
18-85 years
All
Phase 4

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Overview

The goal of this randomized, double-blind, placebo-controlled, 2×2 factorial trial is to evaluate the effect of intraoperative dexmedetomidine combined with either femoral nerve block (FNB) or adductor canal block (ACB) on postoperative sleep quality in patients aged 18-85 years with ASA I-III undergoing elective knee arthroscopy under general anesthesia.

The main questions it aims to answer are:

  1. Does intraoperative dexmedetomidine infusion (0.5 μg/kg/h) improve postoperative sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) at 24 h and 48 h after surgery?
  2. Is there an interaction between the type of nerve block (FNB vs. ACB) and the use of dexmedetomidine on postoperative sleep quality?

Eligibility

Inclusion Criteria:

  1. Age 18 to 85 years.
  2. American Society of Anesthesiologists (ASA) physical status I to III.
  3. Body Mass Index (BMI) between 18 and 30 kg/m² and body weight \> 50 kg.
  4. Scheduled for elective knee arthroscopy under general anesthesia.
  5. Complete preoperative workup, confirmed diagnosis, and indication for knee arthroscopy with complete postoperative medical records.
  6. Normal mental and cognitive status.
  7. Patient or legally authorized representative has provided written informed consent for anesthesia and study participation.

Exclusion Criteria:

  1. Refusal to participate in the study.
  2. Inability to communicate effectively.
  3. Known allergy or contraindication to any study drug (ropivacaine, dexmedetomidine, propofol, sufentanil, remifentanil, vecuronium, or sevoflurane).
  4. History of knee trauma or knee surgery; diagnosed with immune system disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus); neuromuscular diseases or psychiatric disorders; restless legs syndrome (RLS); periodic limb movement disorder (PLMD).
  5. Coagulation disorders or local infection at the puncture site precluding peripheral nerve block.
  6. Severe hepatic or renal dysfunction.
  7. Severe cardiopulmonary insufficiency.
  8. Pregnancy.
  9. Diagnosis of obstructive sleep apnea (OSA) or requirement for continuous positive airway pressure (CPAP) therapy.
  10. Regular use of sedative-hypnotic drugs (benzodiazepines, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) or antidepressants/anxiolytics known to affect sleep architecture (e.g., trazodone, mirtazapine) within the past 1 month.
  11. Pittsburgh Sleep Quality Index (PSQI) score \> 5.

Study details
    Knee Arthroscopic Surgery

NCT07767383

Affiliated Hospital of Nantong University

22 August 2026

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