Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.

Detailed Description
-----------------
Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated. The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.

Official Title
-----------------
Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients

Conditions
-----------------
Elderly ; Moderate Risk Surgery

Intervention / Treatment
-----------------
* Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)
* Procedure: moderate risk surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia Patients who provide written informed consent patient fluent in french Exclusion Criteria: Patients under 70 years of age Surgery under locoregional anesthesia or emergent surgery or minor risk surgery Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery) Patients with arrhythmia and/or atrial fibrillation Patients with preoperative delirium or cognitive dysfunction (moca test < 26) Patients not fluent in French Patients without the capacity to give written informed consent or refusal of consent Patients undergoing surgery or included in another protocol within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring<br>Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider. | Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)<br> <br> Procedure: moderate risk surgery<br> <br> |
| Sham Comparator: Sham<br>Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider | Procedure: moderate risk surgery<br> <br> |
| No Intervention: Control<br>elderly non scheduled for surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative delirium detected by the Confusion Assessment Method (CAM) | Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day | 3 day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative change in cognitive function detected by a battery of neuropsychological test. |  | baseline and 1 week and 3 month postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring