Clinical trial NCT02668250: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary; Ischemic
Arrhythmias, Cardiac
Heart Failure
Peripheral Vascular Diseases
Dementia
Stroke
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Alcoholism
Cancer
Diabetes
Renal Insufficiency
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-01-29
Enrollment: 2495
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of a composite of mortality or major postoperative morbidity.
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens - Picardie
city: Caen
country: France
facility: CHU CAEN
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Dijon
country: France
facility: Chu Dijon
city: Décines-Charpieu
country: France
facility: Médipôle Lyon - Villeurbanne
city: Grenoble 9
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: CHRU Lille - Salengro
city: Lille
country: France
facility: CHU LILLE - Huriez
city: Lyon
country: France
facility: CHU LYON
city: Lyon
country: France
facility: Lyon Sud - CHU
city: Marseille
country: France
facility: Chu Marseille La Timone
city: Marseille
country: France
facility: Chu Marseille Nord
city: Montpellier 5
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: Chu Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU NICE
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Ch Paris Beaujon
city: Paris
country: France
facility: Ch Paris Bichat
city: Paris
country: France
facility: Ch Paris Pitie Salpetriere
city: Paris
country: France
facility: Ch Paris Saint Antoine
city: Paris
country: France
facility: Ch Saint Louis-Lariboisiere
city: Poitiers
country: France
facility: Chu Poitiers
city: Rennes
country: France
facility: Chu Rennes
city: Rouen
country: France
facility: Chu Rouen
city: Saint Etienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: Hopital Central Strasbourg
city: Strasbourg
country: France
facility: Hopital Hautepierre Strasbourg
city: Toulouse 9
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU SAINT-ETIENNE
name: MOLLIEX Serge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molliex S, Passot S, Futier E, Bonnefoi M, Rancon F, Lemanach Y, Pereira B. Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol. BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053.