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Spots Global Cancer Trial Database for Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

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Trial Identification

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

Interventions

OPTI-AGED
Usual Care

Study Description

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.

Keywords

Eligibility

Minimum Age: 75 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MOLLIEX Serge, MD

Affiliation: CHU SAINT ETIENNE

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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