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

NCT04194866 | Unknown

• 1 other identifier: circadian clock
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

circadian clock; postoperative cognitive function; general anesthesia; elderly patients

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Preoperative cognitive function test

  one day before surgery

• Postoperative cognitive function test of 6 weeks after surgery

  6 weeks after surgery

• Postoperative cognitive function test of 1 year after surgery

  1 year after surgery

• Postoperative cognitive function test of 3 years after surgery

  3 years after surgery

Study Arms (2)

Day group

OTHER

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

Night group

OTHER

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

Interventions

receiving operation during the day or at night OTHER

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)

Day group; Night group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• preoperative sleep disorders
• did not receive any preoperative chemoradiotherapy
• the duration of surgery ≧3 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Junchao hospital Zhu

Shenyang, Liaoning, 110004, China

RECRUITING

Study Officials

• Junchao Zhu

  Shengjing Hospital

  STUDY DIRECTOR

Central Study Contacts

Junchao Zhu

CONTACT

18940257257; zhujc@sj-hospital.org

bijia song

CONTACT

18309845273; zhujc@sj-hospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

CN (1)