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

Not Applicable

Withdrawn

• Conditions: Postoperative Delirium
• Interventions: Procedure: Alpha Optimization; Behavioral: Emergence from anesthesia with propofol

• Registration Number: NCT04443517
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-23
• Study Start: 2022-07
• Primary Completion: 2022-12
• Study Completion: 2023-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Maintenance-Alpha Optimization / Wake from Propofol	Emergence from anesthesia with propofol	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.
Maintenance-Routine Care / Wake from Propofol	Emergence from anesthesia with propofol	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.
Maintenance-Alpha Optimization / Wake from Propofol	Alpha Optimization	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.
Maintenance-Alpha Optimization / Wake from Volatile	Alpha Optimization	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.

Primary Outcome Measures

Name	Time	Method
Change in Frontal Alpha Power	Up to 24 hours post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of PACU Delirium	Up to 24 hours post-surgery	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.
Change in pain in PACU: numerical rating score (NRS)	Up to 24 hours post-surgery	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).

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States