NCT07722481

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

July 15, 2026

Last Update Submit

August 1, 2026

Conditions

Keywords

Emergence DeliriumSleep ChronotypeElderly

Outcome Measures

Primary Outcomes (2)

  • Incidence of emergence delirium 1

    Use CAM-ICU

    At 30 minutes after post-anesthesia care unit admission

  • Incidence of emergence delirium 2

    Use CAM-ICU

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

Secondary Outcomes (5)

  • Postoperative CAM-ICU scores 1

    At 30 minutes after post-anesthesia care unit admission

  • Postoperative CAM-ICU scores 2

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

  • Postoperative pain scores 1

    At 30 minutes after post-anesthesia care unit admission

  • Postoperative pain scores 2

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

  • Hospital length of stay

    Up to 12 weeks

Study Arms (2)

morning chronotype group

Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60

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

non-morning chronotype group

Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores \< 60

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

Interventions

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)

morning chronotype groupnon-morning chronotype group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Researchers screened elderly inpatients scheduled to receive general anesthesia at The Second Affiliated Hospital of Chongqing Medical University from October 2024 to March 2025.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 23, 2026

Study Start

October 23, 2024

Primary Completion

March 26, 2025

Study Completion

March 30, 2025

Last Updated

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations