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临床试验/NCT02033629
NCT02033629已完成3 期

Early Extubation After Cardiac Surgery: What Is the Appropriate Target Remifentanil Effect-Site Concentration?

Imam Abdulrahman Bin Faisal University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
75
试验地点
1
主要终点
time to tracheal extubation

研究概览

简要总结

The development of target effect-site controlled concentrations (TCI) of remifentanil have gained increasing acceptance during cardiac surgery as regarding the resulting of hemodynamic stability and early extubation. The use of low-dose opioid technique has been progressively used nowadays because of its ceiling effect to attenuate cardiovascular responses to noxious stimuli. We hypothesize that the use of low target remifentanil effect site concentrations may provide comparable shorter times to tracheal extubation and hemodynamic stability to the use of high remifentanil Ce during target-controlled propofol anesthesia for cardiac surgery.

详细描述

Reducing the time to tracheal extubation and hence the duration of postoperative mechanical ventilation could lessen postoperative complications, improve patients' outcome, shorten the intensive care unit (ICU) stay, and reduce the cost of treatment.

Although high-dose opioid cardiac anesthesia has been shown to provide hemodynamic stability and adequate depth of anesthesia in response to nociceptive stimulation, it may cause delayed recovery and lengthening of the durations for postoperative ventilation support and (ICU length of stay.

The pharmacokinetic-based drug infusion systems, target-controlled infusion (TCI), can rapidly and easily enables changes and maintenance of a constant blood concentration of intravenous anesthetic drugs. We demonstrated that, the use of a TCI of sufentanil at effect-site concentrations (Ce) from 0.2 to 0.3 ng/mL during TCI of propofol anesthesia for valve surgery shortened the times to clinical recovery and extubation.

Remifentanil, a short-acting opioid-receptor agonist with a context-sensitive half-time of 3 to 5 minutes allowing rapid emergence from anesthesia, even after an infusion of several hours. Compared with sufentanil (0.03 to 0.04 µg/kg/min), the use of remifentanil (0.5 to 1.0 µg/kg/min) during propofol anesthesia improved recovery of pulmonary function and shortened postoperative hospital length of stay after coronary artery bypass grafting (CABG).

Furthermore, a TCI of remifentanil at Ce of 1.5-5.0 ng/ml is more effective than a constant-rate infusion in the inhibition of the stress response and the maintenance of the cardiac autonomic nervous system balance during off-pump CABG. Similarly, the lowest remifentanil Ce used in another study of explicit and implicit memory during cardiac surgery under TCI propofol were 2 to 4 ng/ml.

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
Triple (Participant, 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

入选标准

  • Older than 18 years
  • American Society of Anesthesiologists class III and IV
  • eligible for early extubation

排除标准

  • uncontrolled hypertension
  • ischemic heart disease
  • left ventricular ejection fraction ≤45%
  • mean pulmonary artery pressure ≥50 mm Hg
  • critical aortic stenosis
  • pulmonary diseases
  • hepatic diseases
  • renal diseases
  • neuromuscular diseases
  • neuropsychiatric diseases
  • endocrine diseases
  • body mass index ≥40 kg/m2
  • pregnancy
  • use of antipsychotics
  • use of alcohol
  • drug abuse
  • repeat surgery
  • emergency surgery
  • those requiring preoperative circulatory support
  • those whose electrocardiographic characteristics would interfere with ST-segment monitoring

研究组 & 干预措施

Ce 1 ng/ml

Active Comparator

TCI Remifentanil Ce 1 ng/ml

干预措施: Ce 1 ng/ml (Drug)

Ce 2 ng/ml

Active Comparator

TCI Remifentanil Ce 2 ng/ml

干预措施: Ce 2 ng/ml (Drug)

Ce 3 ng/ml

Placebo Comparator

Remifentanil Ce 3 ng/ml

干预措施: Ce 3 ng/ml (Drug)

结局指标

主要结局

time to tracheal extubation

时间窗: for 4 hours after surgery

the times from skin closure to v

次要结局

  • times to spontaneous eye opening(for 5 hours during surgery)
  • times from skin closure to return of spontaneous breathing(for 4 hours after surgery)
  • the number of changes in propofol and remifentanil target infusions(for 6 hours during surgery)
  • Number of patients who will need changes in remifentanil effect site concentrations(For 6 hours during surgery)
  • rescue doses of medications(for 6 hours during surgery)
  • Cost of Medications(for 6 hour during surgery)
  • incidences of light anesthesia(For 6 hours during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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