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NCT Number: NCT07722481

Preoperative Chronotype and Emergence Delirium in the Elderly

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

Other

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)

Primary outcomes

  1. Incidence of emergence delirium 1

    Time frame: At 30 minutes after post-anesthesia care unit admission

    Use CAM-ICU

  2. Incidence of emergence delirium 2

    Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.

    Use CAM-ICU

Secondary outcomes

  1. Postoperative CAM-ICU scores 1

    Time frame: At 30 minutes after post-anesthesia care unit admission

    Use CAM-ICU

  2. Postoperative CAM-ICU scores 2

    Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.

    Use CAM-ICU

  3. Postoperative pain scores 1

    Time frame: At 30 minutes after post-anesthesia care unit admission

    Use the visual analogue scale(VAS)

  4. Postoperative pain scores 2

    Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.

    Use the visual analogue scale(VAS)

  5. Hospital length of stay

    Time frame: Up to 12 weeks

    The period from when the patients enter the hospital until they leave the hospital

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

A Retrospective Study on the Impact of Preoperative Sleep Chronotype on Postoperative Emergence Delirium in Elderly Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2026
Registry last updated
Jul 23, 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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