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Enrolling by invitation NCT07726875

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

— Observational Emergence Delirium, Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Emergence Delirium, Anesthesia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Other No Intervention: Observational Cohort
    No Intervention: Observational Cohort

Primary outcome measures

  • Emergece Delirium [Time frame: During extubation and 20 minutes after extubation]
  • Plasma Orexin [Time frame: During extubation and 20 minutes after extubation]
Secondary outcome measures (1)
  • Postoperative delirium [Time frame: 5 days post- operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07726875 · MR-31-26-052808

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗