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Clinical Trials/NCT05457387
NCT05457387CompletedNot Applicable

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

Chinese PLA General Hospital1 site in 1 country11,927 target enrollmentStarted: April 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11,927
Locations
1
Primary Endpoint
Incidence of postoperative delirium

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Incidence of postoperative delirium

Time Frame: 7 days post surgery

Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily

the incidence of survival rate

Time Frame: 1 year

collection of clinical data in the medical record and follow-up update

Sleep NRS

Time Frame: baseline

sleep numerical rating scale

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chinese PLA General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

Study Sites (1)

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