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

Study on the Correlation Between Plasma Orexin Levels During the Recovery Period and Emergence Delirium in Elderly Patients: A Single-Center, Prospective, Observational Cohort Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Emergence Delirium, Anesthesia
• Intervention / Treatment: Other: No Intervention: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

elderly patients undergoing general anesthesia

Description

Inclusion Criteria:

1. Age is greater than or equal to 60 years old
2. 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
3. ASA I-III

Exclusion Criteria:

1. 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.
2. 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
3. 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)
4. 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.)
5. 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.
6. Having a history of alcohol abuse or drug addiction
7. Emergency surgery, neurosurgery surgery
8. The researchers considered it inappropriate to include in this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Emergence delirium group	Other: No Intervention: Observational Cohort; No Intervention: Observational Cohort
Non-Emergence delirium group	Other: No Intervention: Observational Cohort; No Intervention: Observational Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Delirium	Postoperative delirium is assessed twice daily (8:00-10:00 and 18:00-20:00) from postoperative day 1 through day 5 using the CAM/CAM-ICU scale. A positive finding on any assessment is defined as the occurrence of postoperative delirium. The severity of delirium is evaluated using the DRS-R-98.	5 days post- operation
EEG power in alpha band	EEG power in alpha band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.	From PACU admission to 20 minutes post-extubation
EEG power in beta band	EEG power in beta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.	From PACU admission to 20 minutes post-extubation
EEG power in theta band	EEG power in theta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.	From PACU admission to 20 minutes post-extubation
EEG power in delta band	EEG power in delta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.	From PACU admission to 20 minutes post-extubation

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: MR-31-26-052808

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No