Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Blood sugar concentration
研究概览
简要总结
The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Written informed consent.
- •Ongoing brain functional area surgery with intraoperative wake up.
- •American Society of Anesthesiologists class I to II.
- •Aged between 18 and 65 years old.
- •Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight
排除标准
- •History of hypertension.
- •Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
- •Mental disability or mental disease.
- •Use of sedative drug.
- •Suspected or confirmed long term use of narcotic analgesics.
- •Inability to exchange.
- •Suspected or confirmed difficult airway.
- •Suspected of malignant hyperthermia.
- •Neuromuscular disease.
- •Allergic to investigational products or with other contraindication.
- •Subjects who are breastfeeding or pregnant.
- •Participated in other study within 30 days .
研究组 & 干预措施
Dexmedetomidine group
- Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.
- The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Anesthesia induction,propofol, remifentanil ,cisatracurium (Drug)
Dexmedetomidine group
- Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.
- The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Anesthesia maintenance , propofol,remifentanil,cisatracurium (Drug)
Dexmedetomidine group
- Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.
- The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Awaken test (Procedure)
Control group
- Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.
- Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.
- The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Anesthesia induction,propofol, remifentanil ,cisatracurium (Drug)
Control group
- Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.
- Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.
- The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Anesthesia maintenance , propofol,remifentanil,cisatracurium (Drug)
Control group
- Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.
- Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.
- The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.
干预措施: Awaken test (Procedure)
结局指标
主要结局
Blood sugar concentration
时间窗: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Cortisol concentration
时间窗: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Success rate of awaken test
时间窗: The whole time of surgery,about 8 hours
The time from starting to awaken test to patient wakes up
时间窗: From starting to awaken test to patient wakes up,about 3 hours
Epinephrine concentration
时间窗: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Norepinephrine concentration
时间窗: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
次要结局
- The duration of anesthesia from baseline to patient wake up(From baseline to patient wake up ,about 3 hours)
- Heart rate(30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test)
- The dosage of Cisatracurium before patient wakes up(From starting to awaken test to patient wakes up,about 3 hours)
- Mean arterial pressure(30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test)
- The dosage of remifentanil before patient wakes up(From starting to awaken test to patient wakes up,about 3 hours)
- The dosage of propofol before patient wakes up(From starting to awaken test to patient wakes up,about 3 hours)
- Bispectral electroencephalogram index(30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test)