Influence of the Modality of General Anesthesia Guided by the Bispectral Index (Manual or Automated) on the Occurrence of a Loss of Capability in Elderly Patients (> 70 Yrs): a Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 134
- 试验地点
- 8
- 主要终点
- Rate of patients without occurrence of disability according to the InterRai scale
研究概览
简要总结
The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general anesthesia.
详细描述
To date, patients over the age of 60 yrs represent 25% of the population and are at increased risk of surgical repair. Reduction of postoperative morbidity and mortality are now two main concerns for medical research. Dependence on caregivers and cognitive impairments are two major risks in the elderly and even more in frail patients after surgery under general anesthesia. In this context continuous monitoring of the depth of anesthesia through bispectral index may reduce its occurrence with better control of too deep sedation periods (vasopressors...). Previous studies by the investigators' team suggest a better duration in the expected interval of Bispectral Index with automated control of administration of intravenous anesthetics guided by Bispectral Index. This method remains to be tested in this high-risk population. As a consequence, a randomization into two groups will be carried on elderly patients (> 70 yrs): manual administration of anesthetics guided by Bispectral Index (manual group) or automated administration (automated group). Complete preoperative assessments will determine the FRAIL status (with a decrease in the physiological reserve) and abilities of the patient according to the self-sufficient scale. At six months a follow-up will determine the geriatric status of the patient to explore the rate of impairment and to examine predictive factors in the preoperative assessment. Finally, the influence of the method of administration will be reported. Four hundred and thirty patients will be included in this multicenter study with 215 patients per group and stratification of the presence of a cancer and of the abdominal repair. The follow-up in this study allows the patient or his/her relatives to keep in touch with a physician and to prescribe some therapy early if frailty or any other cognitive impairment appears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged > 70 years old
- •American Society of Anesthesiologists class I to III
- •Scheduled for abdominal surgery under total intra-venous anesthesia
- •Self sufficient (living at home or in a non medical institution)
- •Written consent to the study
排除标准
- •Allergy to any intravenous agent (propofol or remifentanil)
- •Cognitive impairment with a Mini Mental State Examination < 20
- •Severe visual or hearing deficiency, apraxia
- •Restriction of the use of bispectral index
结局指标
主要结局
Rate of patients without occurrence of disability according to the InterRai scale
时间窗: 6 months
Disability is evaluated using the InterRai scale; a death is considered as an irreversible disability institutionalization is considered as a severe disability InterRai scale would discriminate other patients
次要结局
- Mortality at day 28(28 days)
- Incidence of pneumopathy(6 months)
- Rate of postoperative cognitive dysfunction(6 months)
- Incidence of evolution of the frail phenotype(6 months)
- Quality of the general anesthesia(1 day)
- Occurrence of awareness(3 months)
- Incidence of pulmonary embolism(6 months)
- Incidence of postoperative myocardial infarction(6 months)
- Performance of the automated system(1 day)
- Presence of Suppression Ratio(1 day)
- Mortality at month 6(6 months)
- Patients'satisfaction about general anesthesia(1 day)
- Occurrence of arterial hypotension requiring treatment(1 day)