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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
Sponsor:
Information provided by (Responsible Party):
Céline Boudart, Erasme University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
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

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 Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. postoperative change in cognitive function detected by a battery of neuropsychological test. [ Time Frame: baseline and 1 week and 3 month postoperative ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Belgium
Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Study Director: Luc Van Obbergh, MD PhD Erasme Hospital
More Information
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Responsible Party: Céline Boudart, MD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02698982     History of Changes
Other Study ID Numbers: P2015/539
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by Céline Boudart, Erasme University Hospital:
elderly
postoperative cognitive dysfunction
postoperative delirium
depth of anesthesia
intraoperative blood pressure monitoring

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs