An interventional study of Toolbox: Automated group and Manual group in Anesthesia, General and Aged, 70 and Over, sponsored by Hopital Foch. Terminated at 4 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Hopital Foch · Not applicable, Interventional, and Prevention
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.
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.
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Toolbox: Automated administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index through a controller with a previously described algorithm. Objective of depth anesthesia: 40-60
Other: Toolbox: Automated group
Manual administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index as usually performed in the operative theater. Objective of depth anesthesia: 40-60
Other: Manual group
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
Also known as: controller
The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index
Rate of patients without occurrence of disability according to the InterRai scale
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
Time frame: 6 months
Mortality at day 28
Time frame: 28 days
Mortality at month 6
Time frame: 6 months
Rate of postoperative cognitive dysfunction
Cognitive dysfunction is evaluated using the Mini Mental State examination
Time frame: 6 months
Incidence of pneumopathy
Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics
Time frame: 6 months
Incidence of pulmonary embolism
Diagnosis on CT-scan with contrast injection
Time frame: 6 months
Incidence of postoperative myocardial infarction
EKG modification and raised troponin
Time frame: 6 months
Incidence of evolution of the frail phenotype
Frail phenotype accordingly to Fried Scale
Time frame: 6 months
Quality of the general anesthesia
Defined as the time with a Bispectral Index in the interval 40-60
Time frame: 1 day
Performance of the automated system
Defined according to the Varvell score
Time frame: 1 day
Presence of Suppression Ratio
Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute
Time frame: 1 day
Occurrence of arterial hypotension requiring treatment
Defined as a drop of 20% or more of the mean arterial pressure compared to the basal value measured before anesthetic induction and the requirement for a vasoactive agent
Time frame: 1 day
Patients'satisfaction about general anesthesia
Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
Time frame: 1 day
Occurrence of awareness
Postoperative specific questionnaire
Time frame: 3 months
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hopital Foch