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Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

NCT ID: NCT02698982

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Elderly ; Moderate Risk Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Monitoring

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

moderate risk surgery

Intervention Type PROCEDURE

Sham

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

Group Type SHAM_COMPARATOR

moderate risk surgery

Intervention Type PROCEDURE

Control

elderly non scheduled for surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type DEVICE

moderate risk surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Céline Boudart

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Van Obbergh, MD PhD

Role: STUDY_DIRECTOR

Erasme hospital

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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P2015/539

Identifier Type: -

Identifier Source: org_study_id