Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients

NCT07726875 | Enrolling By Invitation

• 1 other identifier: MR-31-26-052808
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the relationship between plasma orexin levels during the recovery period of elderly patients undergoing general anesthesia and the occurrence of emergence delirium, and to evaluate its sensitivity and specificity as an objective diagnostic indicator for emergence delirium

Conditions

Emergence Delirium, Anesthesia

Outcome Measures

Primary Outcomes (2)

• Emergece Delirium

  The CAM-ICU scale is administered at extubation and 20 minutes post-extubation during the PACU stay. A positive finding at either time point is defined as emergence delirium.

  During extubation and 20 minutes after extubation

• Plasma Orexin

  Peripheral venous blood samples (3 mL each) are collected at six time points: 30 minutes before anesthesia induction, after induction but before incision, 1 hour after incision, at volatile anesthetic discontinuation, at extubation, and 20 minutes post-extubation. Samples are placed in EDTA tubes, stored at 2-8°C, centrifuged at 3000 rpm for 15 minutes at 4°C, and the separated plasma is stored at -80°C. Plasma orexin-A levels are measured by ELISA by technicians blinded to group assignment.

  30 minutes before anesthesia induction, after anesthesia induction but before surgical incision, 1 hour after surgical incision, at the time of discontinuation of volatile anesthetics, at extubation, and 20 minutes post-extubation

Secondary Outcomes (5)

• Postoperative Delirium

  5 days post- operation

• EEG power in alpha band

  From PACU admission to 20 minutes post-extubation

• EEG power in beta band

  From PACU admission to 20 minutes post-extubation

• EEG power in theta band

  From PACU admission to 20 minutes post-extubation

• EEG power in delta band

  From PACU admission to 20 minutes post-extubation

Study Arms (2)

Emergence delirium group

Other: No Intervention: Observational Cohort

Non-Emergence delirium group

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

Emergence delirium group; Non-Emergence delirium group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients undergoing general anesthesia

You may qualify if:

• Age is greater than or equal to 60 years old
• It is planned to undergo elective non-cardiac surgery under general anesthesia, with the expected operation duration being greater than or equal to 2 hours
• ASA I-III

You may not qualify if:

• There was a clear diagnosis of mental illness before the surgery (such as schizophrenia, severe depression, etc.) or the patient had been using antidepressants or anti-psychotic drugs for a long time.
• Preoperative presence of sleep-wake disorder-related diseases (such as narcolepsy, untreated moderate to severe obstructive sleep apnea syndrome, etc.) or long-term use of orexin receptor antagonists or agonists
• Preoperatively, there was severe liver dysfunction (Child-Pugh grade B or C), severe renal dysfunction (estimated glomerular filtration rate eGFR \< 30 ml/min/1.73㎡), and severe anemia (Hb \< 80 g/L)
• Perform deep sedation for extubation, plan to transfer to the ICU, or experience severe complications during the recovery period (such as anaphylactic shock, laryngospasm, etc.)
• There are cases where individuals have severe visual or hearing impairments, or are aphasic, and thus are unable to cooperate in completing the cognitive assessment.
• Having a history of alcohol abuse or drug addiction
• Emergency surgery, neurosurgery surgery
• The researchers considered it inappropriate to include in this study

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-07

Locations

CN (1)