Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare 2 groups of adults who are having similar lower-extremity orthopaedic surgeries with regional and propofol anesthesia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harrison S Chow, MD, Msc. | Stanford University | Principal Investigator |
| Yuva Krishnapillai, BS | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medicine Outpatient Center | Redwood City | California | 94063 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41090031 | Background | 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. | |
| 41606493 | Background |
Not provided
Not provided
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
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 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.
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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. |
|
| preoperative baseline (at arrival to pre-induction floor) to early postoperative PACU assessment (within 2 hours of PACU arrival) |
| 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. | preoperative baseline (at arrival to pre-induction floor) to early postoperative PACU assessment (within 2 hours of PACU arrival) |
| 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. | From PACU arrival to discharge in 15 minute increments (within 24 hours) |
| 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. | From PACU arrival to pre-induction until PACU discharge (up to 24 hours) |
| 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. | Within 5 minutes of arrival into PACU |
| 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. | Within 5 minutes of arrival into PACU |
| 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. |
| 40933055 | 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. |
| 41632715 | 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 Jul 1;145(1):21-36. doi: 10.1097/ALN.0000000000005968. Epub 2026 Feb 3. |
| 29108303 | 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. |
| 30915984 | 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. |
| 31436606 | 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. |
| 25264892 | 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. |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided