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Enrolling by invitation

NCT Number: NCT07726875

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

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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Key information

Conditions

Emergence Delirium, Anesthesia Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention: Observational Cohort

Primary outcomes

  1. Emergece Delirium

    Time frame: During extubation and 20 minutes after extubation

    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.

  2. Plasma Orexin

    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

    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.

Secondary outcomes

  1. Postoperative Delirium

    Time frame: 5 days post- operation

    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.

  2. EEG power in alpha band

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

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

  3. EEG power in beta band

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

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

  4. EEG power in theta band

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

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

  5. EEG power in delta band

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

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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