Clinical trial · Interventional
Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcoholism | — | UNRESOLVED | — |
| Arrhythmias, Cardiac | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Coronary; Ischemic | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Peripheral Vascular Diseases | — | UNRESOLVED | — |
| Pulmonary Disease, Chronic Obstructive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPTI-AGED | Procedure | — | UNRESOLVED |
| Usual Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group : OPTI-AGED
- description
- The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
- interventionNames
- Procedure: OPTI-AGED
- type
- ACTIVE_COMPARATOR
- label
- Control Group :
- description
- The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
- interventionNames
- Procedure: Usual Care
Primary outcomes (1)
- measure
- Incidence of a composite of mortality or major postoperative morbidity.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMolliex 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. PMID 29921685