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Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 12, 2016
First Posted Date  ICMJE March 4, 2016
Last Update Posted Date December 26, 2017
Study Start Date  ICMJE May 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
postoperative change in cognitive function detected by a battery of neuropsychological test. [ Time Frame: baseline and 1 week and 3 month postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly
Official Title  ICMJE Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Elderly ; Moderate Risk Surgery
Intervention  ICMJE
  • Device: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)
  • Procedure: moderate risk surgery
Study Arms  ICMJE
  • Experimental: Monitoring
    Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
    Interventions:
    • 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
    Intervention: Procedure: moderate risk surgery
  • No Intervention: Control
    elderly non scheduled for surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
41
Original Estimated Enrollment  ICMJE
 (submitted: February 29, 2016)
45
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698982
Other Study ID Numbers  ICMJE P2015/539
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Céline Boudart, Erasme University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Erasme University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luc Van Obbergh, MD PhD Erasme hospital
PRS Account Erasme University Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP