Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

Free University of Brussels (ULB)

Status: Completed

Conditions: Elderly ; Moderate Risk Surgery

Treatments: Procedure: moderate risk surgery; Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02698982

P2015/539

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 3 patient groups

Monitoring

Experimental group

Description:

Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.

Treatment:

Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)

Procedure: moderate risk surgery

Sham

Sham Comparator group

Description:

Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider

Treatment:

Procedure: moderate risk surgery

Control

No Intervention group

Description:

elderly non scheduled for surgery