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

Not Applicable

Terminated

• Conditions: Anesthesia, General; Aged, 70 and Over
• Interventions: Other: Manual group

• Registration Number: NCT02524327
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07-07
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 134

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual group	Manual 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

Primary Outcome Measures

Name	Time	Method
Rate of patients without occurrence of disability according to the InterRai scale	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

Secondary Outcome Measures

Name	Time	Method
Mortality at day 28	28 days
Incidence of pneumopathy	6 months	Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics
Rate of postoperative cognitive dysfunction	6 months	Cognitive dysfunction is evaluated using the Mini Mental State examination
Incidence of evolution of the frail phenotype	6 months	Frail phenotype accordingly to Fried Scale
Quality of the general anesthesia	1 day	Defined as the time with a Bispectral Index in the interval 40-60
Occurrence of awareness	3 months	Postoperative specific questionnaire
Incidence of pulmonary embolism	6 months	Diagnosis on CT-scan with contrast injection
Incidence of postoperative myocardial infarction	6 months	EKG modification and raised troponin
Performance of the automated system	1 day	Defined according to the Varvell score
Presence of Suppression Ratio	1 day	Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute
Mortality at month 6	6 months
Patients'satisfaction about general anesthesia	1 day	Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
Occurrence of arterial hypotension requiring treatment	1 day	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

Trial Locations

Locations (4)

Hopital Jean Minjoz; 🇫🇷 Besançon, France

Institut Hopsitalier Franco-Britannique; 🇫🇷 Levallois-Perret, France

Centre Clinical; 🇫🇷 Soyaux, France

Hopital Foch; 🇫🇷 Suresnes, France