Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
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ClinicalTrials.gov Identifier: NCT02698982 |
Recruitment Status :
Completed
First Posted : March 4, 2016
Last Update Posted : December 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Elderly ; Moderate Risk Surgery | Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) Procedure: moderate risk surgery | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | March 2017 |
Arm | Intervention/treatment |
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Experimental: Monitoring
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
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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
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Procedure: moderate risk surgery |
No Intervention: Control
elderly non scheduled for surgery
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- postoperative delirium detected by the Confusion Assessment Method (CAM) [ Time Frame: 3 day postoperative ]Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
- postoperative change in cognitive function detected by a battery of neuropsychological test. [ Time Frame: baseline and 1 week and 3 month postoperative ]

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698982
Belgium | |
Erasme Hospital | |
Brussels, Belgium, 1070 |
Study Director: | Luc Van Obbergh, MD PhD | Erasme hospital |
Responsible Party: | Céline Boudart, MD, Erasme University Hospital |
ClinicalTrials.gov Identifier: | NCT02698982 |
Other Study ID Numbers: |
P2015/539 |
First Posted: | March 4, 2016 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
elderly postoperative cognitive dysfunction postoperative delirium depth of anesthesia intraoperative blood pressure monitoring |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |