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

NCT ID: NCT04194866

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Circadian Clock Postoperative Cognitive Function General Anesthesia Elderly Patients

Keywords

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circadian clock postoperative cognitive function general anesthesia elderly patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type OTHER

receiving operation during the day or at night

Intervention Type 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)

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)

Group Type OTHER

receiving operation during the day or at night

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanchao Yang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junchao Zhu

Role: STUDY_DIRECTOR

Shengjing Hospital

Locations

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Junchao hospital Zhu

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junchao Zhu

Role: CONTACT

Phone: 18940257257

Email: [email protected]

bijia song

Role: CONTACT

Phone: 18309845273

Email: [email protected]

Facility Contacts

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Junchao h Zhu

Role: primary

Other Identifiers

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circadian clock

Identifier Type: -

Identifier Source: org_study_id