Dexmedetomidine Combined With Nalbuphine Advanced Analgesia on the Quality of Recovery After General Anesthesia in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- The main outcome of this study was the occurrence of agitation from the time of awakening to 30 minutes after extubation
研究概览
简要总结
Recovery period of general anesthesia refers to the period from the end of anesthesia infusion to recovery of the patient after the operation. In patients with general anesthesia, the depth of anesthesia is reduced in the early stage of recovery, the cerebral cortex is still in a state of inhibition, and the subcortical center is often in a state of high sensitivity to external stimulation. At this time, due to drug effects, pain, hypoxemia, undetected aspiration, pneumothorax, urinary retention, tracheal catheter stimulation, urinary tube stimulation and other factors, the patient will be induced to appear restless reaction, and cause drastic changes in hemodynamics. Especially for the elderly with organ dysfunction, it may increase postoperative complications, prolong hospital stay and increase hospital costs.
详细描述
In recent years, a number of studies have shown that dexmetropil and nalbuphine can reduce postoperative agitation and cough during extubation, respectively, without increasing extubation time. Nalbuphine is a combination of opioid receptor excitation-antagonistic analgesic, which can be combined with μ, κand δ receptors. Nalbuphine has complete excitatory effect on κreceptor and partial antagonistic effect on μ receptor, so it has analgesic and sedative effect. Its analgesic intensity is similar to that of morphine, which can be used to relieve moderate to severe pain and also reduce visceral pain. With little addiction, it can effectively prevent anesthetic stimulation caused by surgical trauma and reduce intraoperative inflammation. Nalbuphine has few cardiovascular side effects, mild respiratory depression and capping effect. As with other agonist antagonists, nabulphine interferes with the adverse reactions associated with pure μ-receptor agonists, such as nausea, vomiting, and pruritus. Dexmedetomidine belongs to an agonist of α2 adrenergic receptor, which has analgesic, sedative, antianxiety, stable kinetics and reducing stress response. It can activate the α2 receptor in the patient's body, thus inhibiting the release of norepinephrine in the patient's body, and then play a role in analgesia, sedation, anti-anxiety.
The main result of this study was the occurrence of agitation within 30 minutes after general anesthesia. The occurrence of agitation was determined by the Riker sedation-excitement score (5-7).
Secondary research indicators:
- EA occurred 0, 10, 20, 30 minutes after extubation by PACU.
- Chills occurred 0, 10, 20, 30 minutes after extubation in PACU.
- Postoperative pain was assessed by visual analogue scale (VAS) at 0, 10, 20 and 30min after extubation by PACU.
- Classification of choking degree within 30 minutes after extubation after recovery
- The changes of vital signs (heart rate, blood pressure and oxygen saturation) were observed at 0min, 10min, 20min and 30min after extubation.
- extubation time: the time from anesthetic withdrawal to extubation.
- Length of hospital stay in PACU: the duration from the end of the operation to the exit of PACU.
- Oxygenation index: The radial artery blood was taken for blood gas analysis before incision, after surgery and 5 minutes after extubation, and the oxygenation index (PaO2/FiO2) was calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age ≥60, gender unlimited;
- •(2) ventilator assisted ventilation after endotracheal intubation;
- •(3) General anesthesia surgery;
排除标准
- •(1) Allergy to the drugs used in this study;
- •(2) any sedative, analgesic, antiemetic or antipruritic drugs taken 24 hours before the operation;
- •(3) History of severe bradycardia (heart rate < 50 beats/min);
- •(4) moderate to severe hepatic and renal dysfunction;
- •(5) Patients with neurological diseases;
研究组 & 干预措施
DEX and Nalbuphine group
In group B, DEX 0.5μg/kg was injected intravenously 30min before the end of the operation, 30min after the pump, and Nalbuphine 0.20 mg/kg (5 mL) was injected intravenously 30min before the end of the operation.
干预措施: Nalbuphine，dexmedetomidine (Drug)
placebo group
Group A was continuously injected with normal saline during the operation, and 5 mL of normal saline was injected intravenously 30min before the end of the operation
干预措施: Nalbuphine，dexmedetomidine (Drug)
nalbuphine group
Group C was continuously injected with normal saline 30 minutes before the end of the operation, and intravenous injection of nalbuphine 0.20 mg/kg (5 mL) 30 minutes before the end of the operation.
干预措施: Nalbuphine，dexmedetomidine (Drug)
结局指标
主要结局
The main outcome of this study was the occurrence of agitation from the time of awakening to 30 minutes after extubation
时间窗: from the time of awakening to 30 minutes after extubation
Riker sedation-excitement score, 5 to 7 points to determine the occurrence of agitation.
次要结局
- postoperation pain(from the time of awakening to 30 minutes after extubation)
- Postoperative cough(from the time of awakening to 30 minutes after extubation)
研究者
Lili Jia
sponsor
Tianjin First Central Hospital