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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 i
• Процедура 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 intraope

Первичные конечные точки

• Time to Meet Post Anesthesia Care Unit (PACU) Discharge Criteria [Срок оценки: Up to 2-5 hours post-surgery with discharge criteria are met.]

Вторичные конечные точки (6)

• Change in Trail Making Test (TMT) time to completion [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From PACU arrival to discharge in 15 minute increments (within 24 hours)]
• Total opioid consumption in the PACU in morphine milligram equivalents [Срок оценки: From PACU arrival to pre-induction until PACU discharge (up to 24 hours)]
• Incidence of dreaming assessed by modified Brice questionnaire [Срок оценки: Within 5 minutes of arrival into PACU]
• Incidence of awareness assessed by modified Brice questionnaire [Срок оценки: Within 5 minutes of arrival into PACU]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Stanford Medicine Outpatient Center — Redwood City

Публикации

• 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
• 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
• 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. PMID 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. PMID 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. eCol PMID 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. PMID 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. PMID 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. PMID 25264892

Идентификаторы

NCT: NCT07533370 · 85351

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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