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

NCT07533370 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Perioperative Care
  • EEG Power Spectra
  • Delirium - Postoperative

Interventions

PROCEDURE

Standard of Care EEG-Guided Emergence

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).

PROCEDURE

Extended EEG Emergence Trajectory

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.

Sponsors & Collaborators

  • Harrison Shong-Wen Chow

    lead OTHER

Principal Investigators

  • Harrison S Chow, MD, Msc. · Stanford University

  • Yuva Krishnapillai, BS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • United States

Study Locations

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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 NCT07533370 on ClinicalTrials.gov