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Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02698982
Enrollment
41
Registered
2016-03-04
Start date
2016-05-31
Completion date
2017-03-31
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly ; Moderate Risk Surgery

Keywords

elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring

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.

Interventions

DEVICEDepth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)
PROCEDUREmoderate risk surgery

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative delirium detected by the Confusion Assessment Method (CAM)3 day postoperativeScreening of postoperative delirium by the CAM, every day until the 3rd postoperative day

Secondary

MeasureTime frame
postoperative change in cognitive function detected by a battery of neuropsychological test.baseline and 1 week and 3 month postoperative

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026