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

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.

Study Overview

• Status: Completed
• 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

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitoring; 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); Procedure: moderate risk surgery
Sham Comparator: Sham; 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
No Intervention: Control; 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	Time Frame
postoperative change in cognitive function detected by a battery of neuropsychological test.	baseline and 1 week and 3 month postoperative

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Director: Luc Van Obbergh, MD PhD, Erasme hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: elderly; postoperative cognitive dysfunction; depth of anesthesia; postoperative delirium; intraoperative blood pressure monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: P2015/539