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

NCT ID: NCT02668250

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2021-03-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group : OPTI-AGED

The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.

Group Type: EXPERIMENTAL

OPTI-AGED

Intervention Type: PROCEDURE

OPTI-AGED is composed of a multi-parametric optimization strategy.

Control Group :

The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: PROCEDURE

Patients receive the usual care.

Interventions

Usual Care

Patients receive the usual care.

Intervention Type: PROCEDURE

OPTI-AGED

OPTI-AGED is composed of a multi-parametric optimization strategy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MOLLIEX Serge, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Amiens - Picardie

Amiens, , France

CHU CAEN

Caen, , France

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Médipôle Lyon - Villeurbanne

Décines-Charpieu, , France

Chu Dijon

Dijon, , France

Chu Grenoble

Grenoble, , 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, , 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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29921685 (View on PubMed)

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1508190

Identifier Type: -

Identifier Source: org_study_id