Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Incidence of awakening agitation
研究概览
简要总结
To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years, with no restriction on gender
- •diagnosis of hip joint disease necessitating hip arthroplasty
- •ASA grade I-II
- •no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation
- •no history of psychiatric disorders or long-term use of sedative medications prior to the operation
- •signing of an informed consent form to voluntarily participate in the study.
排除标准
- •patients allergic to or with contraindications to ropivacaine or dexmedetomidine
- •patients exhibiting symptoms of agitation or delirium prior to the procedure
- •patients with severe central or peripheral nervous system disorders
- •patients with coagulation disorders or receiving anticoagulant therapy
- •pregnant or breastfeeding women
- •patients who received other medications or treatments prior to the procedure that might affect the study results
- •patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block
研究组 & 干预措施
Group S1
Before anesthesia induction, an iliac fascia block was administered using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, dexmedetomidine was infused intravenously at a rate of 0.5 µg/kg/h.
干预措施: Dexmedetomidine Injection (Drug)
Group S2
Before anesthesia induction, an iliac fascia block was administered using a mixture of 0.375% ropivacaine and 1ug/kg dexmedetomidine (30ml) under ultrasound guidance. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.
干预措施: Ropivacaine and Dexmedetomidine (Drug)
Group C
Before anesthesia induction, an iliac fascia block was performed using 0.375% ropivacaine (30 mL) under ultrasound guidance, followed by conventional anesthesia induction. During the anesthesia maintenance phase, an equivalent volume of 0.9% sodium chloride injection was infused intravenously.
干预措施: Sodium Chloride Injection (Drug)
结局指标
主要结局
Incidence of awakening agitation
时间窗: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
Riker sedation-agitation scale (SAS) scores were recorded at various time points during the postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU for each group. These scores were used to evaluate the sedation and agitation status of the patients.
次要结局
- Analgesic effect(postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU)
- Ramesay score(postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU)
- Hemodynamic parameters(During operation)
- Record of laryngeal mask removal time and adverse reactions(Within 24 hours after surgery)
研究者
Pengcai Shi
Chief physician，Master Tutor
Qianfoshan Hospital