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Completed

NCT Number: NCT04246320

Taking Brain Monitoring to the Next Level

This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).

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Key information

About this study

This study will test the hypothesis that a goal directed therapy intervention, which optimizes depth of anesthesia and intraoperative blood pressure can decrease the incidence of postoperative neurocognitive dysfunction

Subjects will be recruited for the study and the protocol explained. In addition to standard American Society of Anesthesiologists (ASA) monitoring, we will monitor continuous non-invasive blood pressure and 4 lead electroencephalogram (EEG) channels. Patients will receive standardized anesthesia care in addition to a goal directed therapy hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

Neurocognitive testing: In order to assess general cognitive function, the Montreal Cognitive Assessment test will be used. Cognitive function will be measured preoperatively and postoperatively at discharge, 1 month and 6 months after surgery. For delirium measurement, we will administer daily the Confusion Assessment Method (CAM-ICU) for up to 3 days.

The Montreal Cognitive Assessment (MoCA) is a screening tool to assess mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructionals skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.

The Wide Range Assessment of Memory and Learning (WRAML2) is a broad-based memory battery that provides a flexible measure of memory functioning and learning and takes approximately 45-60 minutes to administer. This assessment will be conducted at the first MRI visit and at the 6 month follow up.

The Confusion Assessment Method for the ICU (CAM-ICU) screens for the development of delirium and assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The CAM-ICU is positive, and the patient is considered to have delirium, if features 1 and 2 and either feature 3 or 4 are present.

Brain imaging: The timing of pre-operative brain imaging will be as allowed by patient factors and scanner availability, typically less than 15 days before surgery, when the patient comes for the preoperative evaluation, and postoperatively within 2 weeks after surgery.

Optional Blood Draws: Patients will be asked to provide 2 optional blood samples, drawn the day of their brain imaging visit and post-operatively (within 2 days). These samples will be used to asses blood inflammatory biomarkers in obstructive sleep apnea (OSA) subjects and non-OSA subjects between baseline and post-surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 45-75 years old,
  • undergoing abdominal, orthopedic, gynecological, or urological surgery
  • expected to stay in hospital for at least 24hours

Exclusion criteria

  • Substantial hearing impairment or inability to understand English, since there needs to be neurocognitive testing done
  • status post craniotomy
  • severe dementia

Treatment and study plan

Goal directed therapy (GDT)

Other

Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

Primary outcomes

  1. Postoperative cognitive dysfunction

    Time frame: Preoperatively (within 15 days of surgery)

    Montreal Cognitive Assessment (MoCA) test

  2. Postoperative cognitive dysfunction

    Time frame: postoperatively at discharge (within 2 weeks of surgery).

    Montreal Cognitive Assessment (MoCA) test

  3. Postoperative cognitive dysfunction

    Time frame: 6 months after surgery.

    Montreal Cognitive Assessment (MoCA) test

  4. Postoperative Delirium

    Time frame: Daily for up to 3 days postoperatively

    Confusion Assessment Method (CAM-ICU)

Secondary outcomes

  1. Examining brain changes

    Time frame: Typically less than 15 days before surgery, when the patient comes for the preoperative evaluation, postoperatively at up to 48 hours after surgery, and 6 months post surgery

    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  2. Examining brain changes II

    Time frame: postoperatively within 2 weeks of surgery

    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  3. Examining brain changes III

    Time frame: 6 months post surgery

    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  4. Blood anti-inflammatory biomarkers

    Time frame: pre-operatively (within 15 days before surgery)

    Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects

  5. Blood anti-inflammatory biomarkers

    Time frame: post-operatively (within 2 days of surgery)

    Assess blood inflammatory biomarkers (Il6, Il10, TNFa, IL1b, HMGB1) in OSA subjects and non-OSA subjects

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: HDBRAIN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2020
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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