Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- intraoperative consumption of opioids
研究概览
简要总结
Though Cardiac surgery under cardiopulmonary bypass (CPB) under epidural anesthesia in conscious patients is associated with increased risk of epidural hematoma. The investigators developed a monitored anesthesia care (MAC) platform for cardiac surgery under CPB. In the current prospective study, the investigators investigated the safety and effectiveness of the MAC platform versus intubated general anesthesia (IGA) in patients receiving elective open-heart surgery.
The study included adult patients who were scheduled to undergo open-heart surgery under CPB at Shuguang Hospital between April 2012 and December 2021. MAC consisted of local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil and electroacupuncture. MAC versus IGA was chosen by the patients. The investigators will investigate the safety and effectiveness of the MAC platform versus IGA in patients receiving elective open-heart surgery.
详细描述
The detailed description of clinical trial will be published by protocol later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
We set a blind code in case patients have adverse effects. The random code and blind code will be conducted using opaque envelopes by a "third party" independent of the study. The envelopes will be sealed and shuffled, and the assignment records will not be disclosed until the end of the study. Trial participants, cardiothoracic surgeons, anesthesiologists, outcome assessors, and data analysts will be blinded to the treatment allocation to minimize potential sources of bias. Only the nurse of the anesthesiology department (having received specialized acupuncture training) will know the participants' group allocations. However, this nurse will not know any other information about the patients.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA class II or less;
- •expected aortic block time at ≤ 120 min;
- •body mass index (BMI) between 18 and 30 kg/cm2.
排除标准
- •systolic pulmonary blood pressure > 70 mmHg;
- •chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, or simplified airway risk index > 3;
- •Child-Pugh grade B or C liver insufficiency or renal insufficiency (24-h creatinine clearance < 80 mL/min and blood urea nitrogen > 7.5 mmol/L);
- •coagulopathy (aPTT prolongation > 10 seconds versus normal controls, PT prolongation > 3 seconds versus normal controls, and INR > 3.0).
研究组 & 干预措施
MAC group
Electroacupuncture was performed for two consecutive days before surgery (2 daily 30-min sessions) by a licensed acupuncturist at 4.0 mA using an alternating frequency of 2 and 100 Hz (every 1.5 seconds) (LH-202, Huawei, Beijing, China). Acupoints included bilateral Yunmen (LU2), Zhongfu (LU1), Lieque (LU7), and Neiguan (PC6). On the day of surgery, electroacupuncture started upon the completion of a loading dose of dexmedetomidine, was suspended when CPB started (to avoid interference with electrocardiogram recording) and continued until the end of surgery.
干预措施: Non-intubation and monitoring anesthesia care (MAC) (Device)
IGA group
Anesthesia was induced with propofol (2.0-3.5 μg/mL) by target control infusion and 0.3-0.5 μg/kg sufentanil. Tracheal intubation was facilitated by rocuronium (1.0 mg/kg). Anesthesia was maintained using isoflurane at 0.7-1.0 minimal alveolar concentration in a gas mixture of oxygen and air and remifentanil (0.05-0.2 μg·kg-1·min-1) by intravenous injection pump. Sufentanil dose was totally 2.5-4.0 μg/kg. Muscle relaxation was achieved using 1/3-1/4 of the induction dose every 40-60 min based on a train of four. Mechanical ventilation with 80% O2 in air was used. Tidal volume (7-8 mL/kg) and respiratory rate (10-12/min) were adjusted according to PETCO2 to achieve normal ventilation (PETCO2 35-45 mmHg).
结局指标
主要结局
intraoperative consumption of opioids
时间窗: end of the surgery, up to 48 hours after surgery
intraoperative consumption of sufentanil and remifentanil
次要结局
- time to drinking(through study completion, an average of 24 hours)
研究者
Jiangang Song
Director of anesthesiology department of Shuguang Hospital
ShuGuang Hospital