Taking Brain Monitoring to the Next Level

NCT ID: NCT04246320

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2022-08-13

Brief Summary

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).

Detailed Description

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.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Patients monitored and receiving a standard anesthesia plan in addition of a goal directed therapy (GDT) hemodynamic management (MAP \> 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

Group Type: EXPERIMENTAL

Goal directed therapy (GDT)

Intervention Type: OTHER

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

Interventions

Goal directed therapy (GDT)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Kumar, PhD

Professor In-Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh Kumar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Susana Vacas, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, United States

Countries

United States

References

Joosten A, Rinehart J, Bardaji A, Van der Linden P, Jame V, Van Obbergh L, Alexander B, Cannesson M, Vacas S, Liu N, Slama H, Barvais L. Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery: A Randomized Controlled Trial. Anesthesiology. 2020 Feb;132(2):253-266. doi: 10.1097/ALN.0000000000003014.

Reference Type: BACKGROUND

PMID: 31939839 (View on PubMed)

Vacas S, Cannesson M. Noninvasive Monitoring and Potential for Patient Outcome. J Cardiothorac Vasc Anesth. 2019 Aug;33 Suppl 1(Suppl 1):S76-S83. doi: 10.1053/j.jvca.2019.03.045. No abstract available.

Reference Type: BACKGROUND

PMID: 31279357 (View on PubMed)

Other Identifiers

HDBRAIN 16-001040

Identifier Type: -

Identifier Source: org_study_id