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

ConditionsPerioperative CareEEG Power SpectraDelirium - Postoperative
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarrison Shong-Wen Chow

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants with American Society of Anesthesiologists (ASA) physical status I-III

Scheduled for Elective Foot/Ankle Orthopaedic surgery at Stanford Health under planned propofol-based intravenous anesthesia and regional nerve block for preoperative analgesia

Able and willing to complete all cognitive assessments and Brice Interview in PACU

Disqualifiers

ASA physical status IV or V

Chronic opioid therapy

Chronic benzodiazepine use or ongoing treatment with strongly anticholinergic medications within 30 days prior to surgery.

Known major neuro-cognitive disorder, active psychotic disorder, or other severe psychiatric condition that, in the opinion of the investigator, would interfere with valid cognitive testing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care EEG-Guided Emergence

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Foot and ankle surgery with standard of care EEG emergenceActive comparator 1 intervention
Group B: Foot and ankle surgery with extended EEG emergence trajectoryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to Meet Post Anesthesia Care Unit (PACU) Discharge Criteria

Study will measure time in minutes from PACU arrival to the first documentation of institutional PACU discharge criteria being met.

Time frame
Up to 2-5 hours post-surgery with discharge criteria are met.

Secondary outcomes

1

Change in Trail Making Test (TMT) time to completion

TMT Parts A and B is administered preoperatively and again in the early postoperative PACU period to assess attention, processing speed, and executive function. The outcome is the change in completion time (seconds) for TMT-A and TMT-B between postoperative and preoperative assessments (postoperative minus preoperative), with higher values indicating slower performance and worse cognitive function.

Time frame
preoperative baseline (at arrival to pre-induction floor) to early postoperative PACU assessment (within 2 hours of PACU arrival)
2

Change in Digit Symbol Substitution Test (DSST) performance

DSST will be administered preoperatively and postoperatively in the PACU to assess psychomotor speed, attention, and working memory. The outcome is the change in number of correctly matched symbols between postoperative and preoperative assessments (postoperative minus preoperative), with negative values indicating a decline in performance.

Time frame
preoperative baseline (at arrival to pre-induction floor) to early postoperative PACU assessment (within 2 hours of PACU arrival)
3

Pain intensity during PACU stay measured by Numeric Rating Scale (NRS)

Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) during the PACU stay.

Time frame
From PACU arrival to discharge in 15 minute increments (within 24 hours)
4

Total opioid consumption in the PACU in morphine milligram equivalents

All opioid medication dosages will be converted to morphine milligram equivalents (MME) using standard equianalgesic conversion factors, and summed to obtain the total opioid consumption per participant during the PACU stay.

Time frame
From PACU arrival to pre-induction until PACU discharge (up to 24 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harrison Shong-Wen Chow

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov

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