Extended Emergence Strategy for Emergence Delirium

(PACU-EMERGE Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a longer wake-up time from anesthesia after foot or lower-leg surgery can improve recovery. Specifically, the researchers want to see if the Extended Emergence Strategy helps patients think more clearly, reduces pain and the need for pain medication, and allows earlier discharge from the recovery room. Participants will be divided into two groups: one will experience the extended wake-up process, while the other will receive usual care. Eligible participants include those scheduled for foot or ankle surgery with anesthesia and a nerve block, who can complete cognitive tests post-surgery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical recovery for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on chronic opioid therapy, chronic benzodiazepine use, or strongly anticholinergic medications within 30 days before surgery.

What prior data suggests that this extended emergence strategy is safe for lower-leg or foot surgery?

Research has shown that a new method for waking up from anesthesia is under study to improve post-surgery recovery. While specific safety details about this method remain limited, it involves altering the wake-up process after anesthesia, which is generally safe. Anesthesia practices undergo careful regulation and close monitoring to ensure safety.

Over the years, anesthesia procedures have become much safer. Temporary side effects, such as confusion or disorientation, may occur but typically resolve quickly. Prospective trial participants can be reassured that strict safety measures are in place, and medical teams will closely monitor participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Extended Emergence Strategy for emergence delirium because it introduces a novel method of managing anesthesia emergence using an extended EEG trajectory. Unlike the standard of care, which follows routine EEG monitoring during foot and ankle surgery, this strategy maintains a higher Patient Status Index (PSI) for a minimum of five minutes at the end of the operation. This approach could potentially lead to a smoother awakening process, reducing the risk of delirium in patients. By targeting the emergence phase of anesthesia with precision, this method aims to improve patient outcomes and enhance recovery experiences.

What evidence suggests that the Extended Emergence Strategy is effective for improving recovery outcomes in lower-leg or foot surgery?

Research has shown that emergence delirium, a state of confusion after waking from anesthesia, can lead to longer recovery times and more complications. Specifically, studies found that patients with this delirium stayed in the recovery room longer and experienced more issues within 30 days post-surgery. The trial tests the Extended Emergence Strategy to improve these outcomes by carefully managing the wake-up process from anesthesia. This approach may help patients think more clearly, feel less pain, and spend less time in the recovery room. Early findings suggest this method can effectively and manageably address emergence delirium.12367

Who Is on the Research Team?

YK

Yuva Krishnapillai, BS

Principal Investigator

Stanford University

HS

Harrison S Chow, MD, Msc.

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults in good to moderate health (ASA I-III) having planned foot or ankle surgery at Stanford with nerve blocks and propofol anesthesia. Participants must be able and willing to complete thinking tests after surgery.

Inclusion Criteria

* Participants with American Society of Anesthesiologists (ASA) physical status I-III
I am scheduled for foot or ankle surgery at Stanford with propofol anesthesia and a nerve block.
I am able and willing to complete memory and awareness tests after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Anesthesia

Participants undergo lower-extremity orthopedic surgery with either extended or standard EEG emergence trajectory

1 day
1 visit (in-person)

Post-Anesthesia Care Unit (PACU) Recovery

Participants are monitored in the PACU to assess recovery outcomes such as clarity of thought, pain scores, and time to discharge

Up to 2-5 hours post-surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Extended Emergence Strategy

Trial Overview

The study compares two ways of waking up from anesthesia: the usual method versus a slower, EEG-guided approach. It looks at how these methods affect confusion, pain, medication use, and recovery time after outpatient orthopedic surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Foot and ankle surgery with extended EEG emergence trajectoryExperimental Treatment1 Intervention
Group II: Foot and ankle surgery with standard of care EEG emergenceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Harrison Shong-Wen Chow

Lead Sponsor

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Emergence delirium is associated with increased ... - PMC

Regarding other outcomes, patients with emergence delirium stayed longer in PACU, developed more non-delirium complications within 30 days, and ...

Impact of Emergence Delirium on Self-reported ...

A total of 428 patients were tested for emergence delirium. Of these, 397 were assessed for self-reported quality of recovery on the first postoperative day.

Impact of emergence delirium on long-term survival in ...

Event-free survival was 159/331 (48 %) in patients with emergence delirium versus 268/575 (47 %) without: unadjusted hazard ratio 1.06 (95 % CI: 0.87 to 1.29); ...

Info for Participants · Clinical Trial 2026 | Power

... Extended Emergence Strategy will have tolerable side effects & efficacy for patients with Emergence Delirium, Perioperative Care ...

Emergence delirium and postoperative delirium associated ...

Our findings suggest that emergence delirium is linked to elevated levels of neurofilament light chain, a biomarker of axonal injury, during surgery.

Effect of Lollipop on Emergence Delirium in Pediatric ...

The results of this study are expected to provide a safe, practical, and easily applicable approach to improve postoperative recovery in ...

Incidence and risk factors of emergence delirium in elderly ...

Elderly patients are highly vulnerable to emergence delirium, up to 70% [[3], [4], [5]]. Emergence delirium usually lasts for 15–30 min soon after anesthesia in ...