Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

Study Overview
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Brief Summary
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With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Detailed Description
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The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 75) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 75 yrs and over represented only 2.1% of patients undergoing high risk surgery in France (PMSI database), but concentrated 27% of in-hospital deaths. Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Meta-analyses have demonstrated that goal directed hemodynamic therapy significantly reduced mortality and surgical complications in high-risk patients. A lung-protective ventilation strategy in high-risk patients undergoing major abdominal surgery was associated with improved clinical outcome. Retrospective studies indicated that a combination of excessive depth of anesthesia, hypotension and low anesthesia requirement resulted in increased mortality. These approaches of peroperative care remain discussed in the literature and have also to be incorporated in the common clinical practice. Moreover, few of these reviews performed a sensitive analysis in the elderly. Whether a multi-parametric optimization strategy of anesthesia including several specific interventions will impact the short-term postoperative major morbidity and mortality in elderly is not known. The addition of depth of anesthesia monitoring to hemodynamic monitoring and goal directed hemodynamic therapy may improve tissue perfusion by reducing hemodynamic side effects of anesthetic agents, particularly in elderly where the therapeutic window of these agents is reduced. The effects of low protective ventilation may also by additive to the previous measures by reducing the perioperative build-up of oxygen debt. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Official Title
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The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

Conditions
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Coronary; Ischemic, Arrhythmias, Cardiac, Heart Failure, Peripheral Vascular Diseases, Dementia, Stroke, Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Alcoholism, Cancer, Diabetes, Renal Insufficiency

Intervention / Treatment
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* Procedure: OPTI-AGED
* Procedure: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients aged 75 years and over, presenting at least one of the following comorbidities: ischemic coronary disease; cardiac arrhythmia; congestive heart failure; peripheral vascular disease; dementia; stroke; chronic obstructive pulmonary disease; chronic respiratory failure; chronic alcohol abuse; active cancer; diabetes; chronic renal failure A comorbidity index will be measured by using the modified Charlson Comorbidity Index undergoing elective and emergency surgeries including : femoral head fracture, major intraperitoneal abdominal surgery lasting > 90 min (excluding elective cholecystectomy, abdominal wall surgery), vascular surgery (excluding venous surgery and fistula creation) Patient's or patient's relative signed consent form Affiliation to French social assurance system Exclusion Criteria: Acute heart failure and acute coronary syndrome Acute respiratory failure, pneumonia Septic shock Delirium Acute stroke Evolutive neuromuscular disorder Thoracic surgery, combined abdominal and thoracic surgery Surgery performed under exclusive regional anesthesia Patients under tutorship or curatorship Refusal to participate

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group : OPTI-AGED<br>The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia. | Procedure: OPTI-AGED<br>* OPTI-AGED is composed of a multi-parametric optimization strategy.<br>|
| Active Comparator: Control Group :<br>The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care. | Procedure: Usual Care<br>* Patients receive the usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a composite of mortality or major postoperative morbidity. | One or more of major postoperative complications : acute kidney injury (defined by Kidney disease : improving Global Outcomes (KDIGO) stage 1 or higher), acute myocardial infarction, heart failure, stroke, development of sepsisand septic shock, acute respiratory failure requiring non-invasive ventilation or intubation, delirium) will be reported in the source folder of the patients, and the mortality will be also focused. The goal of this study is to decrease this incidence. | Day 30 |