Optimized Anesthesia to Reduce Postoperative Cognitive Impairment in the Elderly

• ClinicalTrials.gov Identifier: NCT02698982
• Recruitment Status: Completed
• First Posted: March 4, 2016
• Last Update Posted: December 26, 2017
• Sponsor: Erasme University Hospital
• Information provided by (Responsible Party): Céline Boudart, Erasme University Hospital

Tracking Information

• First Submitted Date: February 12, 2016
• First Posted Date: March 4, 2016
• Last Update Posted Date: December 26, 2017
• Study Start Date: May 2016
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Elderly ; Moderate Risk Surgery

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2017): 41
• Original Estimated Enrollment (submitted: February 29, 2016): 45
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02698982
• Other Study ID Numbers: P2015/539
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Céline Boudart, Erasme University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Erasme University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Luc Van Obbergh, MD PhD; Erasme hospital

• PRS Account: Erasme University Hospital
• Verification Date: December 2017