NCT07767383 Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery
| NCT ID | NCT07767383 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Knee Arthroscopic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 136 participants in total. It began in 2026-01-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07767383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Knee Arthroscopic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07767383 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07767383 currently recruiting?
Yes, NCT07767383 is actively recruiting participants. Contact the research team at lvy_Ma@ntu.edu.cn for enrollment information.
Where is the NCT07767383 trial being conducted?
This trial is being conducted at Nantong, China.
Who is sponsoring the NCT07767383 clinical trial?
NCT07767383 is sponsored by Affiliated Hospital of Nantong University. The trial plans to enroll 136 participants.