- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722481
Preoperative Chronotype and Emergence Delirium in the Elderly
A Retrospective Study on the Impact of Preoperative Sleep Chronotype on Postoperative Emergence Delirium in Elderly Patients
Emergence delirium (ED) is a prevalent and severe postoperative complication in elderly surgical patients. It can occur at any perioperative stage but most frequently develops during or immediately after emergence from general anesthesia. Characterized by acute agitation and confusion, ED manifests as sharp declines in attention and cognitive function, accompanied by impaired consciousness and disorganized thinking. As a common adverse event in the early postoperative period, ED occurs in up to 87% of critically ill patients, 10%-24% of adult general medical patients, 37%-46% of anesthetized general surgical patients, with the highest incidence of 50% observed in elderly surgical patients during early recovery in the Post-Anesthesia Care Unit (PACU). Anesthesiologists have long attached great importance to the harmful effects of ED on clinical outcomes, as ED elevates risks of postoperative hemorrhage and physical trauma, extends PACU monitoring duration and hospital length of stay, and increases postoperative complications, mortality and medical resource consumption.
Chronotype describes the behavioral manifestation of the endogenous 24-hour circadian timing system. In mammals, circadian rhythms are maintained and regulated by a complete clock system: the central master clock resides in the suprachiasmatic nucleus (SCN) of the hypothalamus, while peripheral clocks exist in organs such as the liver, lungs and skeletal muscle. Patients with delirium commonly suffer severe circadian disturbances, which are embodied in disordered sleep-wake cycles, abnormal secretion rhythms of melatonin and cortisol, and altered expression of clock genes. Chronotypes are conventionally divided into morning, evening and intermediate types. Previous observational studies have proven that chronotype correlates with numerous disorders including metabolic diseases, psychiatric illnesses, brain function, delirium and cognitive performance. Accumulated evidence supports an association between delirium and circadian rhythms, and suggests that circadian dysfunction contributes to the pathological development of delirium.
Nevertheless, few studies have investigated how chronotype affects ED in elderly patients. This study intends to explore the correlation between chronotype and postoperative ED in elderly surgical patients and compare ED incidence among patients with distinct chronotypes. The results of this research will offer scientific references for formulating targeted preventive measures against ED in elderly populations, lower postoperative ED rates, alleviate adverse postoperative events, and optimize long-term clinical prognosis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400010
- The Second Affiliated Hospital of Chongqing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of 65 years or older.
- Scheduled non-cardiac surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Signed informed consent for surgical treatment.
Exclusion Criteria:
- Auditory or verbal impairment.
- Long-term use of psychotropic drugs or alcohol abuse.
- Pre-existing psychiatric disease or cognitive dysfunction.
- A medical history of cerebral infarction, dementia or hypoalbuminemia.
Withdrawal Criteria:
- Surgery duration less than 60 minutes
- Intraoperative blood transfusion
- Intraoperative hypothermia or hypotension
- Intraoperative administration of dexmedetomidine
- Postoperative transfer to intensive care unit
- Requirement for secondary surgical intervention
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60
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Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment
Method for the Intensive Care Unit (CAM-ICU)
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|
non-morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores < 60
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Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment
Method for the Intensive Care Unit (CAM-ICU)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of emergence delirium 1
Time Frame: At 30 minutes after post-anesthesia care unit admission
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Use CAM-ICU
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At 30 minutes after post-anesthesia care unit admission
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Incidence of emergence delirium 2
Time Frame: Within 5 minutes prior to post-anesthesia care unit discharge.
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Use CAM-ICU
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Within 5 minutes prior to post-anesthesia care unit discharge.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative CAM-ICU scores 1
Time Frame: At 30 minutes after post-anesthesia care unit admission
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Use CAM-ICU
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At 30 minutes after post-anesthesia care unit admission
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Postoperative CAM-ICU scores 2
Time Frame: Within 5 minutes prior to post-anesthesia care unit discharge.
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Use CAM-ICU
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Within 5 minutes prior to post-anesthesia care unit discharge.
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Postoperative pain scores 1
Time Frame: At 30 minutes after post-anesthesia care unit admission
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Use the visual analogue scale(VAS)
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At 30 minutes after post-anesthesia care unit admission
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Postoperative pain scores 2
Time Frame: Within 5 minutes prior to post-anesthesia care unit discharge.
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Use the visual analogue scale(VAS)
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Within 5 minutes prior to post-anesthesia care unit discharge.
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Hospital length of stay
Time Frame: Up to 12 weeks
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The period from when the patients enter the hospital until they leave the hospital
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Up to 12 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NO. 2024-193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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