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

C

China Medical University

Status

Unknown

Conditions

Circadian Clock
Postoperative Cognitive Function
General Anesthesia
Elderly Patients

Treatments

Other: receiving operation during the day or at night

Study type

Interventional

Funder types

Other

Identifiers

NCT04194866
circadian clock

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

65 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

Day group
Other group
Description:
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)
Treatment:
Other: receiving operation during the day or at night
Night group
Other group
Description:
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)
Treatment:
Other: receiving operation during the day or at night

Trial contacts and locations

1

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Central trial contact

Junchao Zhu; bijia song

Data sourced from clinicaltrials.gov

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