Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)
研究概览
简要总结
Patients scheduled for elective cardiac surgery are preoperative evaluated using different personality type, stress and anxiety tests.
Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus 1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and propofol 0.06 mg/kg/min).
详细描述
Patients randomized and the type of induction informed to the anaesthetist 30 minutes before surgery.
Patients are monitored before induction of anesthesia. Propofol is started on the randomized infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed. Time to reach BIS < 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •All elective cardiac surgery patients
排除标准
- •Patients requiring special attention or monitoring during induction
- •Patients with expected longer postoperative ventilation time
- •Patients allergic to sufentanil and or propofol
- •Participation in other projects
- •Pregnancy
研究组 & 干预措施
Sufentanil I
Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
干预措施: Sufentanil I (Drug)
Sufentanil I
Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min
干预措施: Propofol I (Drug)
Sufentanil II
Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
干预措施: Sufentanil II (Drug)
Sufentanil II
Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min
干预措施: Propofol II (Drug)
结局指标
主要结局
Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)
时间窗: Up to 30 minutes
Minutes to reach BIS 50
Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit.
时间窗: Up to 24 hours
Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU.
次要结局
- Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score(up to 24 hours)
- Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol(Up to 12 hours)
- Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)(up to 24 hours)
研究者
Carl-Johan Jakobsen
Consultant Anesthesiologist, Ass professor
Aarhus University Hospital