Effect of Dexmedetomidine on Cisatracurium Infusion and Sufentanil Consumption and Its Variations in Different Age Groups, Using a Closed Loop Computer Controlled System.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cisatracurium infusion consumption.
研究概览
简要总结
The purpose of this study is to:
- determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
- analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA status 1 and
- •Consent approval written and oral.
- •Patients scheduled for elective abdominal surgery under general anesthesia.
排除标准
- •Patients with neuromuscular disorders.
- •Patients with history of stroke, flaccid paralysis or other neurological disorders.
- •Significant renal, hepatic or cardiac dysfunction.
- •Consent refusal.
研究组 & 干预措施
P 1
In this group patients were aged from 20 to 45. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.
干预措施: Consumption of cisatracurium and sufentanil in different age groups. (Drug)
P 2
In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.
干预措施: Effect of dexmedetomidine on cisatracurium and sufentanil consumption (Drug)
P 2
In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.
干预措施: Consumption of cisatracurium and sufentanil in different age groups. (Drug)
P 3
In this group patients were aged from 66 to 85. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.
干预措施: Consumption of cisatracurium and sufentanil in different age groups. (Drug)
D
In this group patients were aged from 46to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Dexmedetomidine infusion is started at induction,a bolus dose of 0.5 µg/kg is given over the first hour which is followed by infusion of 0.4 µg/kg/hr.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.
干预措施: Effect of dexmedetomidine on cisatracurium and sufentanil consumption (Drug)
结局指标
主要结局
Cisatracurium infusion consumption.
时间窗: At the time of surgery
Measurements were done during the operation. Cisatracurium infusion was controlled a closed loop computer system. The degree of neuromuscular blockage was assessed every 20 seconds throughout the procedure using the train of four testing. It was done by counting the number and amplitude of twitches evoked after electrical stimulus and the rate of infusion maintained itself at the low rate of 0.20µg/kg/min as long as the T1 response is less than 1%. When the T1 \> 1%, the rate of infusion would automatically increase to 5.0 µg/kg/min until T1 \< 1%, after which the infusion rate would fall back to 0.20µg/kg/min. The controlled infusion described above administered small doses of cisatracurium intra-operatively to maintain a muscle relaxation of more than 99%. The system saved the time and amount of drug given throughout the operation, from which the consumption was calculated in µg/kg/min.
次要结局
- Sufentanil consumption.(At the time of operation.)
研究者
Guolin Wang, MD, PhD, Professor
M.D. PhD. Professor
Tianjin Medical University General Hospital