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Taking Brain Monitoring to the Next Level

NCT04246320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-01-19

No results posted yet for this study

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

Interventions

OTHER

Goal directed therapy (GDT)

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

Sponsors & Collaborators

Principal Investigators

  • Rajesh Kumar, PhD · University of California, Los Angeles

  • Susana Vacas, M.D., Ph.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2022-08-13
Completion
2022-08-13

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246320 on ClinicalTrials.gov