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Enrolling by invitationNCT07726875Updated Aug 18, 2026

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

An observational study in Emergence Delirium, Anesthesia, sponsored by Ruijin Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
60 Years and older
Sex
All
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Study 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

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Conditions studied

  • Emergence Delirium, Anesthesia

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03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's planned enrollment of 150 is close to the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

elderly patients undergoing general anesthesia

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
5 Days
Patient registry
Yes

Groups and cohorts

  • Emergence delirium group

    Other: No Intervention: Observational Cohort

  • Non-Emergence delirium group

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No Intervention: Observational Cohort

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: During extubation and 20 minutes after extubation

  2. 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.

    Time frame: 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

  1. 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.

    Time frame: 5 days post- operation

  2. EEG power in alpha band

    EEG power in alpha band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.

    Time frame: From PACU admission to 20 minutes post-extubation

  3. EEG power in beta band

    EEG power in beta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.

    Time frame: From PACU admission to 20 minutes post-extubation

  4. EEG power in theta band

    EEG power in theta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.

    Time frame: From PACU admission to 20 minutes post-extubation

  5. EEG power in delta band

    EEG power in delta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.

    Time frame: From PACU admission to 20 minutes post-extubation

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Study locations

1 site
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200025, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07726875
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Jul 24, 2026
Start date
Mar 31, 2026
Primary completion
Jan 31, 2027 (estimated)
Completion
Feb 5, 2027 (estimated)
Last update
Aug 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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