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History of Changes for Study: NCT02698982
Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
Latest version (submitted December 22, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 29, 2016 None (earliest Version on record)
2 May 18, 2016 Recruitment Status, Study Status and Contacts/Locations
3 February 9, 2017 Study Status
4 December 22, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02698982
Submitted Date:  February 29, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: P2015/539
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2016
Overall Status: Not yet recruiting
Study Start: March 2016
Primary Completion: December 2016 [Anticipated]
Study Completion: March 2017 [Anticipated]
First Submitted: February 12, 2016
First Submitted that
Met QC Criteria:
February 29, 2016
First Posted: March 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 29, 2016
Last Update Posted: March 4, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Erasme University Hospital
Responsible Party: Principal Investigator
Investigator: Céline Boudart
Official Title: MD
Affiliation: Erasme University Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.

Open or close this module Conditions
Conditions: Elderly ; Moderate Risk Surgery
Keywords: elderly
postoperative cognitive dysfunction
postoperative delirium
depth of anesthesia
intraoperative blood pressure monitoring
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 45 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 70 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Celine F Boudart, MD
Telephone: 3225553919
Email: cboudart@ulb.ac.be
Central Contact Backup: Alexandre Joosten, MD
Telephone: 003225553919
Email: Alendre.Joosten@ulb.ac.be
Study Officials: Luc Van Obbergh, MD PhD
Study Director
Erasme hospital
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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