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Perioperative CarePACU-EMERGENCT07533370

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

A study testing Extended EEG Emergence Trajectory in people with Perioperative Care and EEG Power Spectra, run by Harrison Shong-Wen Chow at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Extended EEG Emergence Trajectory
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Jul 2026to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • Active cardiac or neurological stimulators or pumps in use
  • Severe uncorrected visual or hearing impairment that precludes valid cognitive battery or interview completion.
Show all 9Show fewer
  • Inability to speak and understand the study language sufficiently to provide informed consent and complete study assessments.
  • Inability to provide informed consent or lack of a legally authorized representative when required.
  • Concurrent participation in another interventional study that could confound PACU cognitive or delirium outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Stanford Medicine Outpatient Center

    Redwood City, California, 94063

    Harrison S Chow, MD, Msc.

    Makoto Kawai, MD, Dsc.

Other trials in United States

About this study

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

Being tested
Standard of Care EEG-Guided Emergence, Extended EEG Emergence Trajectory
Keywords
Post-anesthesia care unit (PACU), Postoperative delirium, EEG-guided anesthesia, Neurocognitive outcomes
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care EEG-Guided EmergenceProcedure or 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 TrajectoryProcedure or 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.

Study groups in NCT07533370
Study groupRoleWhat they receive
Foot and ankle surgery with standard of care EEG emergenceActive comparatorParticipants undergoing routine foot and ankle surgery will be given a routine standard of care intraoperatively at standard Patient Status Index (PSI) readings.
Receives: Procedure: Standard of Care EEG-Guided Emergence
Foot and ankle surgery with extended EEG emergence trajectoryExperimentalParticipants 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.
Receives: Procedure: Extended EEG Emergence Trajectory

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2-5 hours post-surgery with discharge criteria are met.

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From PACU arrival to pre-induction until PACU discharge (up to 24 hours)

  5. Incidence of dreaming assessed by modified Brice questionnaire

    A modified Brice questionnaire will be administered after anesthesia to assess intraoperative dreaming, including any explicit recall of events and reports of dream experiences.

    Measured: Within 5 minutes of arrival into PACU

  6. Incidence of awareness assessed by modified Brice questionnaire

    A modified Brice questionnaire will be administered after anesthesia to assess intraoperative awareness, including any explicit recall of events and reports of dream experiences.

    Measured: Within 5 minutes of arrival into PACU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group randomized controlled trial in which the eligible ambulatory lower extremity orthopedic outpatients are randomized one-to-one to one of two emergence strategies. Participants in both arms receive the same surgical procedures, anesthetic agents and regional blocks per institutional standards. Only the intraoperative emergence management differs, e.g. EEG guided gradual pre-emergence vs. standard EEG-guided emergence. Each participant is assigned to a single arm for the duration of the study and outcomes are compared between arms on an intention-to-treat basis.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533370
Sponsor's protocol ID
85351
Acronym
PACU-EMERGE
Status last verified
May 2026
First submitted
8 Apr 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the primary and secondary outcome analyses will be shared, including a data dictionary and coding manual. No direct identifiers will be included

Publications

  • Qin X, Chen X, Zhao X, Yao L, Niu H, Li K, Zhao Y, Liang Z, Lan Z, Wang Y, Guo X, Huang J, Li X. Electroencephalogram prediction of propofol effects on neuromodulation in disorders of consciousness. Front Neurol. 2025 Sep 29;16:1637647. doi: 10.3389/fneur.2025.1637647. eCollection 2025.

    PubMed 41090031
  • Chen Y, Zou Y, Zhao X, Zhang L. Effects of EEG-guided anesthetic depth monitoring on delirium incidence across different age groups: a systematic review and meta-analysis. BMC Anesthesiol. 2026 Jan 28;26(1):153. doi: 10.1186/s12871-026-03631-3.

    PubMed 41606493
  • Ren X, Huiqiao L, Wu Y, Zhang T, Chen P, Li L, Zhao G, Wang F. Perioperative neurocognitive disorders: a comprehensive review of terminology, clinical implications, and future research directions. Front Neurol. 2025 Aug 26;16:1526021. doi: 10.3389/fneur.2025.1526021. eCollection 2025.

    PubMed 40933055
  • Sikka P, Ngo MC, Hu S, Wilkerson TB, Shull M, Imbordino K, Ishii T, Kawai M, Deverett B, Chow HS, Heifets BD. Feasibility of a Multicomponent Protocol to Promote Dreaming during Surgical Anesthesia. Anesthesiology. 2026 Jul 1;145(1):21-36. doi: 10.1097/ALN.0000000000005968. Epub 2026 Feb 3.

    PubMed 41632715
  • Cascella M, Fusco R, Caliendo D, Granata V, Carbone D, Muzio MR, Laurelli G, Greggi S, Falcone F, Forte CA, Cuomo A. Anesthetic dreaming, anesthesia awareness and patient satisfaction after deep sedation with propofol target controlled infusion: A prospective cohort study of patients undergoing day case breast surgery. Oncotarget. 2017 Apr 19;8(45):79248-79256. doi: 10.18632/oncotarget.17238. eCollection 2017 Oct 3.

    PubMed 29108303
  • Hesse S, Kreuzer M, Hight D, Gaskell A, Devari P, Singh D, Taylor NB, Whalin MK, Lee S, Sleigh JW, Garcia PS. Association of electroencephalogram trajectories during emergence from anaesthesia with delirium in the postanaesthesia care unit: an early sign of postoperative complications. Br J Anaesth. 2019 May;122(5):622-634. doi: 10.1016/j.bja.2018.09.016. Epub 2018 Oct 25.

    PubMed 30915984
  • Zierau M, Li D, Lapointe AP, Ip KI, McKinney AM, Thompson A, Puglia MP, Vlisides PE. Cortical Oscillations and Connectivity During Postoperative Recovery. J Neurosurg Anesthesiol. 2021 Jan;33(1):87-91. doi: 10.1097/ANA.0000000000000636.

    PubMed 31436606
  • Chander D, Garcia PS, MacColl JN, Illing S, Sleigh JW. Electroencephalographic variation during end maintenance and emergence from surgical anesthesia. PLoS One. 2014 Sep 29;9(9):e106291. doi: 10.1371/journal.pone.0106291. eCollection 2014.

    PubMed 25264892

Questions about this trial

What is this clinical trial studying?

A study testing Extended EEG Emergence Trajectory in people with Perioperative Care and EEG Power Spectra, run by Harrison Shong-Wen Chow at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07533370, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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