Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457387
• Other study ID #: PLAGH-POD-002
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11927
• Est. completion date: July 11, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Dyssomnias
• Parasomnias
• Postoperative Delirium

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

Beijing Anzhen Hospital, Beijing Tiantan Hospital, China-Japan Friendship Hospital, First Affiliated Hospital of Xinjiang Medical University, Fudan University, Peking University First Hospital, Peking University People's Hospital, Sun Yat-sen University, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year
Primary	Sleep NRS	sleep numerical rating scale	1 day before the surgery
Primary	Sleep NRS	sleep numerical rating scale	7 days post surgery
Primary	Sleep NRS	sleep numerical rating scale	baseline