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

August 25, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2495

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Chu Amiens - Picardie
      • Caen, France
        • CHU Caen
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand
      • Dijon, France, 21079
        • CHU Dijon
      • Décines-Charpieu, France
        • Médipôle Lyon - Villeurbanne
      • Grenoble 9, France, 38043
        • CHU Grenoble
      • Lille, France, 59000
        • CHRU Lille - Salengro
      • Lille, France, 59037
        • CHU LILLE - Huriez
      • Lyon, France
        • CHU Lyon
      • Lyon, France
        • Lyon Sud - CHU
      • Marseille, France, 13385
        • Chu Marseille La Timone
      • Marseille, France, 13385
        • CHU Marseille Nord
      • Montpellier 5, France, 34295
        • CHU Montpellier
      • Nancy, France, 54035
        • CHU Nancy
      • Nantes, France
        • CHU de Nantes
      • Nice, France
        • CHU Nice
      • Nîmes, France
        • CHU Nîmes
      • Paris, 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
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rennes, France
        • CHU Rennes
      • Rouen, France, 76031
        • CHU Rouen
      • Saint Etienne, France, 42100
        • CHU Saint Etienne
      • Strasbourg, France, 67098
        • Hôpital Hautepierre Strasbourg
      • Strasbourg, France, 67098
        • Hopital Central Strasbourg
      • Toulouse 9, France, 31059
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

71 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group : OPTI-AGED
The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Procedure: OPTI-AGED
OPTI-AGED is composed of a multi-parametric optimization strategy.
Active Comparator: Control Group :
The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
Procedure: Usual Care
Patients receive the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of a composite of mortality or major postoperative morbidity.
Time Frame: 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.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: MOLLIEX Serge, MD, CHU Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Actual)

February 5, 2020

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508190
  • ANSM (Other Identifier: 2026-A01275-46)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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