Emergence DeliriumNCT07722481
Preoperative Chronotype and Emergence Delirium in the Elderly
An observational study of Emergence Delirium, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Intraoperative blood transfusion
- Intraoperative hypothermia or hypotension
- Intraoperative administration of dexmedetomidine
- Postoperative transfer to intensive care unit
- Requirement for secondary surgical intervention
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: An Observational Study on the Influence of Preoperative Sleep Time Types on Postoperative 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.
- Conditions
- Emergence Delirium
- Being tested
- the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
- Keywords
- Emergence Delirium, Sleep Chronotype, Elderly
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| morning chronotype group | Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60 Receives: 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 Receives: Other: the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium 1
Use CAM-ICU
Measured: At 30 minutes after post-anesthesia care unit admission
Incidence of emergence delirium 2
Use CAM-ICU
Measured: Within 5 minutes prior to post-anesthesia care unit discharge.
Secondary outcomes (5)
Postoperative CAM-ICU scores 1
Use CAM-ICU
Measured: At 30 minutes after post-anesthesia care unit admission
Postoperative CAM-ICU scores 2
Use CAM-ICU
Measured: Within 5 minutes prior to post-anesthesia care unit discharge.
Postoperative pain scores 1
Use the visual analogue scale（VAS）
Measured: At 30 minutes after post-anesthesia care unit admission
Postoperative pain scores 2
Use the visual analogue scale（VAS）
Measured: Within 5 minutes prior to post-anesthesia care unit discharge.
Hospital length of stay
The period from when the patients enter the hospital until they leave the hospital
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start23 Oct 2024
- Primary completion26 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722481
- Sponsor's protocol ID
- NO. 2024-193
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Influence of Preoperative Sleep Time Types on Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT07722481
- Acronym / sponsor ID
- NO. 2024-193
- Conditions
- Emergence Delirium
- Keywords
- Emergence Delirium, Sleep Chronotype, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning chronotype group | – | Other: the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60 |
| non-morning chronotype group | – | Other: the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores < 60 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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：
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)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) | Other | morning chronotype group, non-morning chronotype group |
Primary outcome
Incidence of emergence delirium 1
Time frame: At 30 minutes after post-anesthesia care unit admission
Use CAM-ICU
Incidence of emergence delirium 2
Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.
Use CAM-ICU
5 secondary outcomes
Postoperative CAM-ICU scores 1
Time frame: At 30 minutes after post-anesthesia care unit admission
Postoperative CAM-ICU scores 2
Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.
Postoperative pain scores 1
Time frame: At 30 minutes after post-anesthesia care unit admission
Postoperative pain scores 2
Time frame: Within 5 minutes prior to post-anesthesia care unit discharge.
Hospital length of stay
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium 1 (time frame: At 30 minutes after post-anesthesia care unit admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.