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

NCT07533370 | Not Yet Recruiting DMC

• 1 other identifier: 85351
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Post-anesthesia care unit (PACU); Postoperative delirium; EEG-guided anesthesia; Neurocognitive outcomes

Outcome Measures

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.

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

Study Arms (2)

Foot and ankle surgery with standard of care EEG emergence

ACTIVE COMPARATOR

Participants undergoing routine foot and ankle surgery will be given a routine standard of care intraoperatively at standard Patient Status Index (PSI) readings.

Procedure: Standard of Care EEG-Guided Emergence

Foot and ankle surgery with extended EEG emergence trajectory

EXPERIMENTAL

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.

Procedure: Extended EEG Emergence Trajectory

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).

Foot and ankle surgery with standard of care EEG emergence

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.

Foot and ankle surgery with extended EEG emergence trajectory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Severe uncorrected visual or hearing impairment that precludes valid cognitive battery or interview completion.
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Related Publications (8)

• 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.

  PMID: 41090031 BACKGROUND

• 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.

  PMID: 41606493 BACKGROUND

• 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.

  BACKGROUND

• 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 Feb 3. doi: 10.1097/ALN.0000000000005968. Online ahead of print.

  PMID: 41632715 BACKGROUND

• 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.

  PMID: 29108303 BACKGROUND

• 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. Erratum In: Br J Anaesth. 2019 Aug;123(2):255. doi: 10.1016/j.bja.2019.05.033.

  PMID: 30915984 BACKGROUND

• 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.

  PMID: 31436606 BACKGROUND

• 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.

  PMID: 25264892 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Harrison S Chow, MD, Msc.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) and supporting documentation will be made available beginning 6-12 months after publication of the primary results manuscript and will remain available for at least 5 years thereafter.
• Access Criteria: Access will be granted to qualified investigators affiliated with academic or non-profit institutions for non-commercial, IRB-approved research projects that are consistent with the consent provided by participants. Requestors will be required to submit a brief research proposal and sign a data use agreement. After approval, data will be shared via secure, password-protected transfer or an institutional data repository.

Locations

US (1)