Extended Emergence Strategy on Post-Anesthesia Care Unit Events After Outpatient Orthopedic Surgery

Part of paid clinical trials in Redwood City, California.

Sponsor
Harrison Shong-Wen Chow
Study ID
NCT07533370
Status
Not Yet Recruiting

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Conditions

  • Delirium - Postoperative
  • EEG Power Spectra
  • Perioperative Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standard of Care EEG-Guided Emergence — PROCEDURE
    Participants in this arm will undergo standard-of-care emergence from general anesthesia, with anesthetic management and timing of emergence determined by the treating anesthesiologist according to usual institutional practice. Continuous frontal EEG monitoring will be available as part of routine intraoperative monitoring; however, anesthetic discontinuation, adjustment of anesthetic dose, and timing of tracheal extubation will not follow a protocolized extended EEG target (for example, there is no requirement to maintain PSI greater than 50 for a predefined duration before extubation).
  • Extended EEG Emergence Trajectory — PROCEDURE
    Participants receive protocolized extended emergence guided by continuous frontal EEG monitoring during the final phase of anesthesia. Anesthesiologists will titrate anesthetic dosing to achieve and maintain a pre-specified emergence EEG pattern characterized by a persistent, organized posterior-dominant beta rhythm and return of higher-frequency activity, corresponding to a Patient State Index (PSI) greater than 50 for at least 5 consecutive minutes before tracheal extubation. Standard intraoperative hemodynamic and respiratory management will be maintained per routine care.

Study Details

The goal of this clinical trial is to learn if an extended emergence from anesthesia can improve recovery room (Post-Anesthesia Care Unit or PACU) outcomes in lower-leg or foot surgery with nerve blocks. The primary questions it aims to answer are: * Does a longer wake-up help participants think more clearly soon after surgery compared with usual approaches? * Does it lower pain scores, lower the amount of pain medications used, and shorten the time it takes to go home from recovery room? Researchers will compare 2 groups of adults who are having similar lower-extremity orthopaedic surgeries with regional and propofol anesthesia.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Foot and ankle surgery with standard of care EEG emergence
    Participants undergoing routine foot and ankle surgery will be given a routine standard of care intraoperatively at standard Patient Status Index (PSI) readings.
  • Experimental: Foot and ankle surgery with extended EEG emergence trajectory
    Participants undergoing routine foot and ankle surgery will be given an experimental EEG emergence trajectory at end-operation held at PSI greater than 50 for a minimum of 5 minutes.

Primary Outcome Measure

Time to Meet Post Anesthesia Care Unit (PACU) Discharge Criteria [ Time Frame: Up to 2-5 hours post-surgery with discharge criteria are met. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Medicine Outpatient CenterRedwood CityCalifornia94063
Harrison S Chow, MD, Msc. (PRINCIPAL_INVESTIGATOR)
Makoto Kawai, MD, Dsc. (SUB_INVESTIGATOR)

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By research site
Stanford Medicine Outpatient Center· Redwood City, CA

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