Taking Brain Monitoring to the Next Level

NCT04246320 | Completed

• 1 other identifier: HDBRAIN 16-001040
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium; Obstructive Sleep Apnea

Keywords

goal directed therapy (GDT); magnetic resonance imaging (MRI); neurocognitive testing

Outcome Measures

Primary Outcomes (4)

• Postoperative cognitive dysfunction

  Montreal Cognitive Assessment (MoCA) test

  Preoperatively (within 15 days of surgery)

• Postoperative cognitive dysfunction

  Montreal Cognitive Assessment (MoCA) test

  postoperatively at discharge (within 2 weeks of surgery).

• Postoperative cognitive dysfunction

  Montreal Cognitive Assessment (MoCA) test

  6 months after surgery.

• Postoperative Delirium

  Confusion Assessment Method (CAM-ICU)

  Daily for up to 3 days postoperatively

Secondary Outcomes (5)

• Examining brain changes

  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

• Examining brain changes II

  postoperatively within 2 weeks of surgery

• Examining brain changes III

  6 months post surgery

• Blood anti-inflammatory biomarkers

  pre-operatively (within 15 days before surgery)

• Blood anti-inflammatory biomarkers

  post-operatively (within 2 days of surgery)

Study Arms (1)

Intervention

EXPERIMENTAL

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).

Other: Goal directed therapy (GDT)

Interventions

Goal directed therapy (GDT) OTHER

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

Intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

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

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 31939839 BACKGROUND

• 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.

  PMID: 31279357 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium; Sleep Apnea, Obstructive

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Rajesh Kumar, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Susana Vacas, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor In-Residence

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 29, 2020
• Study Start: January 30, 2020
• Primary Completion: August 13, 2022
• Study Completion: August 13, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)