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Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

Examining the Association Between Perioperative Sleep Disturbance and Postoperative Delirium During Non-cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05457387
Enrollment
11927
Registered
2022-07-14
Start date
2020-04-01
Completion date
2022-07-11
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Brief summary

The investigators are performing this research study to understand the role of sleep disturbance on the incidence of delirium after surgery.

Detailed description

Sleep is one of the most important physiological needs. Sleep disturbances have detri-mental effects on practically all systems and may thus prolong recovery of patients. Studies have documented many similarities between clinical and physiological profiles of patients with delirium and sleep disturbances (ischemia/inflammation, hypoxia, neu-rotransmitter imbalance and tryptophan/melatonin metabolism abnormalities). There is still a lack of strong evidence to support the link between poor sleep and delirium, par-ticularly in hospitalized patients, even though available studies suggest that sleep dis-turbances may be a potential key risk factor for its development, which may have a significant clinical impact. Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted. The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Interventions

None listed

Sponsors

China-Japan Friendship Hospital
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Beijing Tiantan Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
Beijing Anzhen Hospital
CollaboratorOTHER
Peking University People's Hospital
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Sun Yat-sen University
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
The Affiliated Hospital Of Guizhou Medical University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
Taihe Hospital
CollaboratorOTHER
Zhejiang Provincial People's Hospital
CollaboratorOTHER
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Geriatric surgical patients ≥65 years old

Exclusion criteria

Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative delirium7 days post surgeryOccurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
the incidence of survival rate1 yearcollection of clinical data in the medical record and follow-up update
Sleep NRS1 day before the surgerysleep numerical rating scale

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026