The Effect of Dexmedetomidine Subsidiary Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia：A Randomized, Double Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 212
- 主要终点
- Ramsay sedation score
研究概览
简要总结
Evaluate safety and efficacy of dexmedetomidine in minimally invasive spine surgery under local anesthesia sedation.Explore the appropriate concentration of dexmedetomidine, whether or not can reduce the amount of local anesthetics.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent；
- •American Society of Anesthesiologists (ASA)classification:class I~II;Elective minimally invasive spine surgery；
- •Age ≥18 years old, weighing 45 ~ 80 Kg, height 151 ~ 185 cm;
- •hypertension within Ⅱ grade, or controlled with drugs within Ⅱ level；
- •Diabetes fasting in 8.3mol/L or less
排除标准
- •DEX allergy;
- •Change anesthesia preoperative or intraoperative ;
- •metabolic disorders, anemia has not been corrected;
- •recent patients receiving sedatives and antidepressants;
- •degenerative diseases of the central nervous elderly persons;
- •serious central nervous system diseases (acute stroke, uncontrolled epilepsy, severe dementia);
- •hypovolemia; 8) unstable angina or acute myocardial infarction;
- •left ventricular ejection fraction less than 30%, heart rate lower than 45bpm;
- •II-III degree heart block;
- •acute hepatitis or severe liver disease (liver function C level);
- •patients with renal insufficiency randomly assigned to receive treatment, but If patients need dialysis test is excluded or interruption ;
研究组 & 干预措施
Low-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
干预措施: Dexmedetomidine (Drug)
Low-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
干预措施: Lidocaine (Drug)
Low-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
干预措施: Low-dose Dexmedetomidine (Drug)
Moderate-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
干预措施: Dexmedetomidine (Drug)
Moderate-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
干预措施: Lidocaine (Drug)
Moderate-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
干预措施: Moderate-dose Dexmedetomidine (Drug)
High-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
干预措施: Dexmedetomidine (Drug)
High-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
干预措施: Lidocaine (Drug)
High-dose Dexmedetomidine
load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
Local anesthesia: lidocaine maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
干预措施: High-dose Dexmedetomidine (Drug)
normal saline Control group
Intravenous injection normal saline equal quantity，completed within 10 minutes. Local anesthesia: lidocaine Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery
干预措施: Lidocaine (Drug)
normal saline Control group
Intravenous injection normal saline equal quantity，completed within 10 minutes. Local anesthesia: lidocaine Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery
干预措施: normal saline (Drug)
结局指标
主要结局
Ramsay sedation score
时间窗: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.
visual analogue scale
时间窗: From 1min before dexmedetomidine infusion to 2h after surgery，up to 4 hours
Evaluation time point：1min before dexmedetomidine infusion；1min before local anesthesia；lidocaine infiltrate layer by layer to the periosteum，assessed up to 2min；Intraoperative most painful moments，assessed up to 5min；1min before returning to the ward；2h after surgery.Intraoperative most painful moments：nucleus pulpous probe or Balloon Dilatation.
次要结局
- The total amount of lidocaine(2h after surgery；)
- The patient and the surgeon satisfaction(2h after surgery；)