Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery: A Randomized Controlled Factorial Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after surgery
研究概览
简要总结
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:
- 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?
- Is there an interaction between the type of nerve block (FNB vs. ACB) and the use of dexmedetomidine on postoperative sleep quality?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 85 years.
- •American Society of Anesthesiologists (ASA) physical status I to III.
- •Body Mass Index (BMI) between 18 and 30 kg/m² and body weight > 50 kg.
- •Scheduled for elective knee arthroscopy under general anesthesia.
- •Complete preoperative workup, confirmed diagnosis, and indication for knee arthroscopy with complete postoperative medical records.
- •Normal mental and cognitive status.
- •Patient or legally authorized representative has provided written informed consent for anesthesia and study participation.
排除标准
- •Refusal to participate in the study.
- •Inability to communicate effectively.
- •Known allergy or contraindication to any study drug (ropivacaine, dexmedetomidine, propofol, sufentanil, remifentanil, vecuronium, or sevoflurane).
- •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).
- •Coagulation disorders or local infection at the puncture site precluding peripheral nerve block.
- •Severe hepatic or renal dysfunction.
- •Severe cardiopulmonary insufficiency.
- •Diagnosis of obstructive sleep apnea (OSA) or requirement for continuous positive airway pressure (CPAP) therapy.
- •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.
- •Pittsburgh Sleep Quality Index (PSQI) score > 5.
研究组 & 干预措施
FNB + Placebo
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: ropivacaine (local infiltration) (Drug)
FNB + Placebo
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: Normal saline placebo (Drug)
FNB + Placebo
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: Femoral Nerve Block (Procedure)
FNB + Dexmedetomidine
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: ropivacaine (local infiltration) (Drug)
FNB + Dexmedetomidine
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: Femoral Nerve Block (Procedure)
ACB + Placebo
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: ropivacaine (local infiltration) (Drug)
ACB + Placebo
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: Normal saline placebo (Drug)
ACB + Placebo
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
干预措施: Adductor canal block (Procedure)
ACB + Dexmedetomidine
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: ropivacaine (local infiltration) (Drug)
ACB + Dexmedetomidine
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: Adductor canal block (Procedure)
ACB + Dexmedetomidine
Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: Dexmedetomidine (Drug)
FNB + Dexmedetomidine
Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after surgery
时间窗: 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.
次要结局
- Pittsburgh Sleep Quality Index (PSQI) scores at 48 hours after surgery(48 hours after surgery)
- Richards-Campbell Sleep Questionnaire (RCSQ) Score at 24 Hours After Surgery(24 hours after surgery)
- Richards-Campbell Sleep Questionnaire (RCSQ) Score at 48 Hours After Surgery(48 hours post-surgery)
- Resting Pain Numeric Rating Scale Score at 6 Hours After Surgery(6 hours after surgery)
- Resting Pain Numeric Rating Scale Score at 24 Hours After Surgery(24 hours after surgery)
- Resting Pain Numeric Rating Scale Score at 48 Hours After Surgery(48 hours after surgery)
- Movement Pain Numeric Rating Scale Score at 6 Hours After Surgery(6 hours after surgery)
- Movement Pain Numeric Rating Scale Score at 24 Hours After Surgery(24 hours after surgery)
- Movement Pain Numeric Rating Scale Score at 48 Hours After Surgery(48 hours after surgery)
- Total Sufentanil Consumption(0 to 24 hours)
- Quality of Recovery-15 (QoR-15) score at 24 Hours After Surgery(24 hours after surgery)
- Quality of Recovery-15 (QoR-15) score at 48 Hours After Surgery(48 hours after surgery)
- Modified Bromage score at 6 Hours After Surgery(6 hours after surgery)
- Modified Bromage score at 24 Hours After Surgery(24 hours after surgery)
- Quadriceps Muscle Strength Score at 6 Hours After Surgery(6 hours after surgery)
- Quadriceps Muscle Strength Score at 24 Hours After Surgery(24 hours after surgery)
- Quadriceps Muscle Strength Score at 48 Hours After Surgery(48 hours after surgery)
- Time to First Assisted Ambulation(From the end of surgery to first assisted ambulation, assessed up to 48 hours after surgery)
- Mini-Mental State Examination (MMSE) score(Baseline and 24 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting(0 to 48 hours after surgery)
- Proportion of Participants Requiring Rescue Analgesia(From the end of surgery through 48 hours after surgery)
- Incidence of Perioperative Adverse Events(From the start of anesthesia to 48 hours after surgery)