Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia

Postoperative Delirium Clinical Trial

Official title:

Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04443517
• Other study ID #: AAAS4614
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: August 2023

Study information

• Verified date: August 2021
• Source: Columbia University
• Contact: Paul S. Garcia, MD, PhD
• Phone: 212-304-7678
• Email: pg2618[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: August 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Procedure:
• Alpha Optimization
Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of desflurane and opioid.

Behavioral:
• Emergence from anesthesia with propofol
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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 hours post-surgery
Secondary	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.	Up to 24 hours post-surgery
Secondary	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).	Up to 24 hours post-surgery