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

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

Study Overview

• Status: Unknown
• Conditions: General Anesthesia; Elderly Patients; Postoperative Cognitive Function; Circadian Clock
• Intervention / Treatment: Other: receiving operation during the day or at night

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junchao Zhu; Phone Number: 18940257257 18940257257; Email: zhujc@sj-hospital.org
• Study Contact Backup: Name: bijia song; Phone Number: 18309845273; Email: zhujc@sj-hospital.org

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Junchao hospital Zhu
      • Contact: Junchao h Zhu; Phone Number: 18940257257 18940257257; Email: zhujc@sj-hospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Day group; 60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group ( 8:00-12:00)	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)
Other: Night group; 60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: general anesthesia; circadian clock; elderly patients; postoperative cognitive function
• Other Study ID Numbers: circadian clock

Drug and device information, study documents

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