Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index (FRAGIL)

Hopital Foch

Status: Terminated

Conditions: Aged, 70 and Over; Anesthesia, General

Treatments: Other: Toolbox: Automated group; Other: Manual group

Study type: Interventional

Funder types: Other

Identifiers

NCT02524327

2014/28

2014-A01270-47 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 134 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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134 participants in 2 patient groups

Toolbox: Automated group

Experimental group

Description:

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

Treatment:

Other: Toolbox: Automated group

Manual group

Active Comparator group

Description:

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

Treatment:

Other: Manual group