Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium

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 Type: Observational
• Enrollment (Actual): 11927

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital based group

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year
Incidence of postoperative delirium	Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily	7 days post surgery
Sleep NRS	sleep numerical rating scale	1 day before the surgery
Sleep NRS	sleep numerical rating scale	7 days post surgery
Sleep NRS	sleep numerical rating scale	baseline

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University First Hospital; Xiangya Hospital of Central South University; Peking University People's Hospital; Sun Yat-sen University; Fudan University; Beijing Tiantan Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Anzhen Hospital; China-Japan Friendship Hospital; Wuhan Union Hospital, China; Zhejiang University; The Affiliated Hospital Of Guizhou Medical University; Zhejiang Provincial People's Hospital; First Affiliated Hospital of Xinjiang Medical University; Taihe Hospital
• Investigators: Study Chair: Weidong G Mi, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Dyssomnias; Parasomnias
• Other Study ID Numbers: PLAGH-POD-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No