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Brief Title: Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality
Official Title: 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
Study ID: NCT02668250
Brief Summary: 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: 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.
Minimum Age: 75 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU Amiens - Picardie, Amiens, , France
CHU CAEN, Caen, , France
Chu Clermont-Ferrand, Clermont-Ferrand, , France
Chu Dijon, Dijon, , France
Médipôle Lyon - Villeurbanne, Décines-Charpieu, , France
Chu Grenoble, Grenoble 9, , France
CHRU Lille - Salengro, Lille, , France
CHU LILLE - Huriez, Lille, , France
CHU LYON, Lyon, , France
Lyon Sud - CHU, Lyon, , France
Chu Marseille La Timone, Marseille, , France
Chu Marseille Nord, Marseille, , France
Chu Montpellier, Montpellier 5, , France
Chu Nancy, Nancy, , France
CHU de Nantes, Nantes, , France
CHU NICE, Nice, , France
Chu Nimes, Nîmes, , France
Ch Paris Beaujon, Paris, , France
Ch Paris Bichat, Paris, , France
Ch Paris Pitie Salpetriere, Paris, , France
Ch Paris Saint Antoine, Paris, , France
Ch Saint Louis-Lariboisiere, Paris, , France
Chu Poitiers, Poitiers, , France
Chu Rennes, Rennes, , France
Chu Rouen, Rouen, , France
Chu Saint Etienne, Saint Etienne, , France
Hopital Central Strasbourg, Strasbourg, , France
Hopital Hautepierre Strasbourg, Strasbourg, , France
Chu Toulouse, Toulouse 9, , France
Name: MOLLIEX Serge, MD
Affiliation: CHU SAINT ETIENNE
Role: PRINCIPAL_INVESTIGATOR