Recruiting
Phase 4
Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery
Condition(s) studied
Knee Arthroscopic Surgery
Investigational drug(s) / intervention(s)
ropivacaine (local infiltration)DexmedetomidineNormal saline placeboFemoral Nerve BlockAdductor canal block
ropivacaine (local infiltration): 0.375% ropivacaine solution, 20 mL, administered as a single-shot peripheral nerve block prior to anesthesia induction.
Dexmedetomidine: 0.5 μg/(kg·h) continuous intravenous infusion, initiated after anesthesia induction and discontinued 30 minutes before the end of surgery.
Normal saline placebo: 0.9% normal saline solution, administered as a continuous intravenous infusion at a volume rate matching the dexmedetomidine group (0.5 μg/kg/h equivalent), started after induction and stopped 30 minutes before surgery end.
Femoral Nerve Block: Ultrasound-guided femoral nerve block performed at the inguinal region (approximately 2 cm distal to the inguinal ligament) using an in-plane technique. A total of 20 mL of 0.375% ropivacaine is injected 1-2 mm anterior to the femoral nerve.
Adductor canal block: Ultrasound-guided adductor canal block performed via the distal approach at the mid-to-lower third of the medial thigh, targeting the adductor hiatus. A total of 20 mL of 0.375% ropivacaine is injected.
Study summary
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.
Primary outcome measure(s)
- Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after surgery — 24 hours post-surgery
Sleep quality at 24 hours after surgery will be assessed using the Pittsburgh Sleep Quality Index. The unit of measure is points on a scale. The Pittsburgh Sleep Quality Index includes 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component score ranges from 0 to 3. The global Pittsburgh Sleep Quality Index score is calculated as the sum of the 7 component scores, resulting in a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The Affiliated Hospital of Nantong University |
Nantong |
Jiangsu |
Recruiting |
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