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

RecruitingPhase 4Ages 18 Years - 85 YearsAllAffiliated Hospital of Nantong University
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized, double-blind, placebo-controlled, 2ร—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 ฮผg/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?

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mยฒ 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.
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What it tests

  • ropivacaine (local infiltration)
  • Dexmedetomidine
  • Normal saline placebo
  • Femoral Nerve Block
  • Adductor canal block
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Where

1 site
The Affiliated Hospital of Nantong University
Nantong, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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