The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients

General Anesthesia Clinical Trial

Official title:

The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194866
• Other study ID #: circadian clock
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2019
• Source: Shengjing Hospital
• Contact: Junchao Zhu
• Phone: 18940257257
• Email: zhujc[@]sj-hospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and above. It refers to the cognitive function changes such as memory decline and attention loss after anesthesia and surgery. In serious cases, people may also experience personality changes and decline in social behavior ability, which will develop into irreversible cognitive impairment.Some studies reported that 25.8% of elderly patients presented POCD one week after non-cardiac surgery, and the incidence at 3 months after surgery was still 9.9%, which could increase the mortality in the first year after surgery.In recent years, studies have also proved that POCD is associated with patients' inability to perform their original jobs after non-cardiac surgery.Postoperative cognitive dysfunction seriously affects the clinical outcome, in addition to medical costs and other issues will bring an impact on the society and family.With the aging of the population, how to prevent cognitive dysfunction in elderly patients is a major challenge for perioperative management.There is a certain correlation between circadian rhythm and the dosage of general anesthesia, and postoperative sleep disturbance may be related to the effect of anesthesia and surgery on circadian rhythm.Preoperative sleep deprivation is known to be an independent risk factor for postoperative cognitive dysfunction (POCD), but the circadian mechanisms involved after general anesthesia are not yet clear

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• preoperative sleep disorders

• did not receive any preoperative chemoradiotherapy

• the duration of surgery ?3 hours

Exclusion Criteria:

• History of schizophrenia

• epilepsy

• parkinson's disease or myasthenia gravis

• Critical illness (preoperative American society of anesthesiologists (ASA) ASA >III)

• severe liver insufficiency (ChildePugh grade C)

• severe renal insufficiency (preoperative dialysis)

• neurosurgery

Related Conditions & MeSH terms

• Circadian Clock
• Elderly Patients
• General Anesthesia
• Postoperative Cognitive Function

Intervention

Other:
• receiving operation during the day or at night
120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)

Locations

Country	Name	City	State
China	Junchao hospital Zhu	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative sleep quality of one night before surgery	use sleep monitor to test the sleep quality one night before surgery	one night before the surgery
Primary	postoperative sleep quality of first night after surgery	use sleep monitor to test the sleep quality first night after surgery	the first night after surgery
Primary	postoperative sleep quality of third night after surgery	use sleep monitor to test the sleep quality third night after surgery	the third night after surgery
Secondary	Preoperative cognitive function test	use MMSE(Mini-mental state examination) scale to test the cognitive function one day before surgery. MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities. Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0	one day before surgery
Secondary	Postoperative cognitive function test of 6 weeks after surgery	use MMSE(Mini-mental state examination) scale to test the cognitive function 6 weeks after surgery. MMSE is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities. Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0	6 weeks after surgery
Secondary	Postoperative cognitive function test of 1 year after surgery	use MMSE(Mini-mental state examination) scale to test the cognitive function 1 year after surgery. MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities. Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0	1 year after surgery
Secondary	Postoperative cognitive function test of 3 years after surgery	use MMSE(Mini-mental state examination) scale to test the cognitive function 3 years after surgery. MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities. Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0	3 years after surgery