NCT07533370

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

Extended Emergence Trajectory on Post-Anesthesia Care Units Events in Ambulatory Lower-Extremity Orthopedic Surgery: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-06-01
• Completion: 2027-10-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States