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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07726875
Enrollment
150
Registered
2026-07-24
Start date
2026-03-31
Completion date
2027-02-05
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Anesthesia

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

Interventions

OTHERNo Intervention: Observational Cohort

No Intervention: Observational Cohort

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergece DeliriumDuring extubation and 20 minutes after extubationThe 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.
Plasma Orexin30 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-extubationPeripheral 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

MeasureTime frameDescription
EEG power in beta bandFrom PACU admission to 20 minutes post-extubationEEG power in beta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
Postoperative Delirium5 days post- operationPostoperative 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.
EEG power in delta bandFrom PACU admission to 20 minutes post-extubationEEG power in delta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
EEG power in theta bandFrom PACU admission to 20 minutes post-extubationEEG power in theta band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.
EEG power in alpha bandFrom PACU admission to 20 minutes post-extubationEEG power in alpha band is continuously recorded throughout the entire emergence period using the Pearlcare EEG monitor.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026