Clinical trial NCT05457387: Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium
Official title: Examining the Association Between Perioperative Sleep Disturbance and Postoperative Delirium During Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Fudan University
name: Beijing Tiantan Hospital
name: Peking University First Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiangya Hospital of Central South University
name: Beijing Anzhen Hospital
name: Peking University People's Hospital
name: Zhejiang University
name: Sun Yat-sen University
name: Wuhan Union Hospital, China
name: The Affiliated Hospital Of Guizhou Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: Taihe Hospital
name: Zhejiang Provincial People's Hospital
First posted: 2022-07-14
Enrollment: 11927
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based group

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 7 days post surgery
measure: the incidence of survival rate
timeFrame: 1 year
measure: Sleep NRS
timeFrame: 1 day before the surgery
measure: Sleep NRS
timeFrame: 7 days post surgery
measure: Sleep NRS
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong G Mi, PhD
role: STUDY_CHAIR
References: