Back to resultsModulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia
Primary Purpose
Postoperative Delirium
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alpha Optimization
Emergence from anesthesia with propofol
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Delirium focused on measuring EEG, General Anesthesia
Eligibility Criteria
Inclusion Criteria:
- Adults aged 60 years or over
- Has capacity to provide informed consent
- Undergoing elective non-cardiac surgery, which does not involve the head or neck, with planned volatile-based general anesthesia of expected duration of at least 2 hours
Exclusion Criteria:
- Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g. carbamazepine, phenytoin,
- Illicit substance use or excessive alcohol intake
- Refusal by patient or case anesthesiologist responsible for patient's care
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
Maintenance-Alpha Optimization / Wake from Propofol
Maintenance-Alpha Optimization / Wake from Volatile
Maintenance-Routine Care / Wake from Propofol
Maintenance-Routine Care / Wake from Volatile
Arm Description
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioid. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive real-time monitoring of alpha recordings and individualized titration of desflurane and opioid. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
Outcomes
Primary Outcome Measures
Incidence of PACU Delirium
3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM), Confusion Assessment Method for the ICU (CAM-ICU), Speech / Language Assessment will be administered to check for signs of delirium.
Secondary Outcome Measures
Change in Frontal Alpha Power
The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.
Change in pain in PACU: numerical rating score (NRS)
The numerical rating score (NRS) requires the patient to rate their pain from 0-10 where 0 is no pain and 10 is the worst pain imaginable (high score indicates worse outcome).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04443517
Brief Title
Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia
Official Title
Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators intend to recruit 600 participants to see if alpha power during anesthesia is influenced by analgesic medication and associated with a reduction of delirium following surgery.
Detailed Description
Postoperative delirium may manifest in the immediate post-anesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anesthesia medication to proprietary index targets for preventing delirium remains contentious. The investigators aim to assess the efficacy of two pharmacologic strategies which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the emergence phases of anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
EEG, General Anesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maintenance-Alpha Optimization / Wake from Propofol
Arm Type
Experimental
Arm Description
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioid. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
Arm Title
Maintenance-Alpha Optimization / Wake from Volatile
Arm Type
Active Comparator
Arm Description
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive real-time monitoring of alpha recordings and individualized titration of desflurane and opioid. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
Arm Title
Maintenance-Routine Care / Wake from Propofol
Arm Type
Active Comparator
Arm Description
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
Arm Title
Maintenance-Routine Care / Wake from Volatile
Arm Type
No Intervention
Arm Description
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
Intervention Type
Procedure
Intervention Name(s)
Alpha Optimization
Intervention Description
Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of desflurane and opioid.
Intervention Type
Behavioral
Intervention Name(s)
Emergence from anesthesia with propofol
Intervention Description
Infusion of 400 mg/h of propofol during the final 10-20 minutes of surgery. Total doses of propofol administered are likely to be in the range of 1-3 mg/kg.
Primary Outcome Measure Information:
Title
Incidence of PACU Delirium
Description
3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM), Confusion Assessment Method for the ICU (CAM-ICU), Speech / Language Assessment will be administered to check for signs of delirium.
Time Frame
Up to 24 hours post-surgery
Secondary Outcome Measure Information:
Title
Change in Frontal Alpha Power
Description
The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.
Time Frame
Up to 24 hours post-surgery
Title
Change in pain in PACU: numerical rating score (NRS)
Description
The numerical rating score (NRS) requires the patient to rate their pain from 0-10 where 0 is no pain and 10 is the worst pain imaginable (high score indicates worse outcome).
Time Frame
Up to 24 hours post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults aged 60 years or over
Has capacity to provide informed consent
Undergoing elective non-cardiac surgery, which does not involve the head or neck, with planned volatile-based general anesthesia of expected duration of at least 2 hours
Exclusion Criteria:
Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g. carbamazepine, phenytoin,
Illicit substance use or excessive alcohol intake
Refusal by patient or case anesthesiologist responsible for patient's care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul S. Garcia, MD, PhD
Phone
212-304-7678
Email
pg2618@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tuan Z. Cassim, BA
Phone
917-539-9926
Email
tc3032@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S. Garcia, MD, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul S. Garcia, MD, PhD
Phone
212-304-7678
Email
pg2618@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Tuan Z. Cassim, BA
Phone
917-539-9926
Email
tc3032@cumc.columbia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia
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