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

Not Applicable

Completed

• Conditions: Coronary; Ischemic; Dementia; Alcoholism; Diabetes; Heart Failure; Peripheral Vascular Diseases; Arrhythmias, Cardiac; Stroke; Respiratory Insufficiency; Cancer
• Interventions: Procedure: OPTI-AGED; Procedure: Usual Care

• Registration Number: NCT02668250
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2017-02-03
• Primary Completion: 2020-02-05
• Study Completion: 2021-03-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2495

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group : OPTI-AGED	OPTI-AGED	The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Control Group :	Usual Care	The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.

Primary Outcome Measures

Name	Time	Method
Incidence of a composite of mortality or major postoperative morbidity.	Day 30	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.

Trial Locations

Locations (29)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Amiens - Picardie; 🇫🇷 Amiens, France

CHU CAEN; 🇫🇷 Caen, France

Chu Dijon; 🇫🇷 Dijon, France

Médipôle Lyon - Villeurbanne; 🇫🇷 Décines-Charpieu, France

CHRU Lille - Salengro; 🇫🇷 Lille, France

Chu Grenoble; 🇫🇷 Grenoble 9, France

CHU LILLE - Huriez; 🇫🇷 Lille, France

CHU LYON; 🇫🇷 Lyon, France

Chu Nancy; 🇫🇷 Nancy, France

Chu Montpellier; 🇫🇷 Montpellier 5, France

Chu Marseille Nord; 🇫🇷 Marseille, France

Lyon Sud - CHU; 🇫🇷 Lyon, France

Chu Marseille La Timone; 🇫🇷 Marseille, France

CHU NICE; 🇫🇷 Nice, France

Chu Nimes; 🇫🇷 Nîmes, France

CHU de Nantes; 🇫🇷 Nantes, France

Ch Paris Beaujon; 🇫🇷 Paris, France

Ch Paris Bichat; 🇫🇷 Paris, France

Ch Paris Pitie Salpetriere; 🇫🇷 Paris, France

Ch Saint Louis-Lariboisiere; 🇫🇷 Paris, France

Ch Paris Saint Antoine; 🇫🇷 Paris, France

Chu Poitiers; 🇫🇷 Poitiers, France

Chu Rennes; 🇫🇷 Rennes, France

Chu Saint Etienne; 🇫🇷 Saint Etienne, France

Hopital Central Strasbourg; 🇫🇷 Strasbourg, France

Hopital Hautepierre Strasbourg; 🇫🇷 Strasbourg, France

Chu Rouen; 🇫🇷 Rouen, France

Chu Toulouse; 🇫🇷 Toulouse 9, France