跳至主要内容
临床试验/NCT02711384
NCT02711384已完成不适用

Minimum Alveolar Concentration of Sevoflurane for Maintaining BIS Below 50 in Patients Undergoing Coronary Artery Bypass Grafting During Normothermic Cardiopulmonary Bypass Phase.

Instituto Dante Pazzanese de Cardiologia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
MACBIS50 in patients undergoing CAG during normothermic CPB phase.

研究概览

简要总结

Background: We determined the minimum alveolar concentration (MAC) of sevoflurane for maintaining bispectral index (BIS) below 50 (MACBIS50) in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase. Method: Fifteen patients, American Society of Anestesiology physical status III or IV, aged 40-70, undergoing elective coronary artery bypass grafting, were enrolled in our study. The predetermined target end-tidal sevoflurane concentration was maintained for at least ten minutes during normothermic cardiopulmonary bypass phase. BIS values were then recorded at an interval of 10 s for 1 min. The dial settings were adjusted to attain an end-tidal sevoflurane concentration of 1% in the first patient. If a given patient had an average BIS of < 50, the sevoflurane concentration was reduced by 0.1% in the subsequent patient, whereas if a given patient had a BIS ≥ 50, the sevoflurane concentration was increased by 0.1% in the next patient. MACBIS50 was calculated using the midpoint concentration of patients involving a crossover according to the up-down method. Average of the crossover midpoints in each pair defined effective dose 50. Data were also analyzed by a logistic regression test to obtain the probability of BIS < 50 versus end-tidal sevoflurane concentration. Result: MACBIS50 of sevoflurane was 0,82% (95% confidence intervals: 0,47-1,16) in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase. Conclusion: MACBIS50 determined in this study was 15% lower compared to MACBIS50 in middle-aged adults after tracheal intubation.

详细描述

Minimum alveolar concentration (MAC) is defined as the minimum alveolar concentration at sea level of inhaled anaesthetic required to prevent apparently purposeful movement in 50% of patients in response to surgical incision1,2. A similar approach to the one described to ascertain MAC has been used to determine the potency of inhaled anaesthetics for other desirable clinical end-points of general anaesthesia, such as to maintain bispectral index (BIS) below 50 (MACBIS50). Therefore, MACBIS50 is defined as the minimum alveolar concentration of inhaled anaesthetic for maintaining BIS below 50 in 50% of patients. MACBIS50 was determined in different age groups and clinical conditions of patients, but not in cardiac surgery3-5.

This study aims to determine the minimum alveolar concentration of sevoflurane for maintaining bispectral index below 50 in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase.

Methods After obtaining approval from the institutional ethics committee and written informed consent, fifteen patients, American Society of Anestesiology physical status III or IV, aged 40-70, undergoing elective coronary artery bypass grafting, were enrolled in our study. Exclusion criteria included history of psychiatric or neurological diseases, drug abuse or medications that affect the central nervous system, pregnancy, combined surgeries, reoperation in cardiac surgery, emergency procedures and neuraxial block.

No premedication was given. Intraoperative monitoring consisted of a five-lead ECG, pulse oximetry, gas analyzer, bladder catheterization, invasive arterial pressure in the radial artery, esophageal thermometer, central venous catheter inserted through the subclavian vein, transesophageal echocardiography (when indicated), train-of-four monitoring (TOF) and BIS (BIS Vista™; Covidien). Breath-by-breath inspired/end-tidal sevoflurane and carbon dioxide (CO2) concentrations were measured with a multigas analyzer and it was calibrated before each experiment. The anaesthetic system used was a semi-closed system (Primus® - Draeger).

Anesthesia was induced with sevoflurane in 6 L.min-1 oxygen using the incremental increase technique via a face mask until the loss of consciousness and BIS value between 40-60. After then sufentanil (0.5 µg.kg-1) and pancuronium (0.1 µg.kg-1) were given and assisted ventilation was started. The T4/T1 ratio was measured using the TOF every minute until orotracheal intubation. The patient was intubated with the following parameters: BIS value between 40-60 and TOF = 0. Mechanical ventilation was initiated using controlled-volume mode (tidal volume of 6 mL.kg-1, ventilatory frequency of 12-15 bpm, PEEP of 5 mmHg and minute ventilation adjusted to maintain end-tidal carbon dioxide tension with the range of 35-40 mmHg). Neuromuscular block was maintained under deep block (TOF = 0 and PTC ≥ 1) using pancuronium up to one hour before the end of the procedure. Anesthesia was maintained using sufentanil (1 µg.kg-1 before the surgical incision) and up to 1 MAC of the end-tidal sevoflurane to maintain a BIS between 40-60. Continuous norepinephrine infusion was started if the mean arterial pressure was less than 60 mmHg.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anestesiology physical status III or IV;
  • Aged 40-70;
  • Undergoing elective coronary artery bypass grafting.

排除标准

  • History of psychiatric or neurological diseases;
  • Drug abuse or medications that affect the central nervous system;
  • Pregnancy;
  • Combined surgeries;
  • Reoperation in cardiac surgery;
  • Emergency procedures;
  • Neuraxial blockade.

结局指标

主要结局

MACBIS50 in patients undergoing CAG during normothermic CPB phase.

时间窗: 1 year

To determine the minimum alveolar concentration of sevoflurane for maintaining bispectral index below 50 in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Gustavo dos Santos Silva

MD

Instituto Dante Pazzanese de Cardiologia

研究点 (1)

Loading locations...

相似试验