Back to resultsOptimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
Primary Purpose
Elderly ; Moderate Risk Surgery
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)
moderate risk surgery
Sponsored by
About this trial
This is an interventional prevention trial for Elderly ; Moderate Risk Surgery focused on measuring elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring
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
Sites / Locations
- Erasme Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Monitoring
Sham
Control
Arm Description
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider
elderly non scheduled for surgery
Outcomes
Primary Outcome Measures
postoperative delirium detected by the Confusion Assessment Method (CAM)
Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
Secondary Outcome Measures
postoperative change in cognitive function detected by a battery of neuropsychological test.
Full Information
NCT ID
NCT02698982
First Posted
February 12, 2016
Last Updated
December 22, 2017
Sponsor
Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02698982
Brief Title
Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
Official Title
Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly ; Moderate Risk Surgery
Keywords
elderly, postoperative cognitive dysfunction, postoperative delirium, depth of anesthesia, intraoperative blood pressure monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring
Arm Type
Experimental
Arm Description
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider
Arm Title
Control
Arm Type
No Intervention
Arm Description
elderly non scheduled for surgery
Intervention Type
Device
Intervention Name(s)
Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)
Intervention Type
Procedure
Intervention Name(s)
moderate risk surgery
Primary Outcome Measure Information:
Title
postoperative delirium detected by the Confusion Assessment Method (CAM)
Description
Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
Time Frame
3 day postoperative
Secondary Outcome Measure Information:
Title
postoperative change in cognitive function detected by a battery of neuropsychological test.
Time Frame
baseline and 1 week and 3 month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Van Obbergh, MD PhD
Organizational Affiliation
Erasme hospital
Official's Role
Study Director
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
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Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
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