Circadian ClockNCT04194866
The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
A study testing receiving operation during the day or at night in people with Circadian Clock and Postoperative Cognitive Function, run by Shengjing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Circadian Clock, Postoperative Cognitive Function, General Anesthesia
- What is being tested?
- receiving operation during the day or at night
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- preoperative sleep disorders
- did not receive any preoperative chemoradiotherapy
- the duration of surgery ≧3 hours
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junchao hospital Zhu
Shenyang, Liaoning, 110004
Junchao h Zhu, 18940257257 ext. 18940257257, zhujc@sj-hospital.org
About this study
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
- Being tested
- receiving operation during the day or at night
- Keywords
- circadian clock, postoperative cognitive function, general anesthesia, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receiving operation during the day or at nightOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: receiving operation during the day or at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sleep quality of one night before surgery
use sleep monitor to test the sleep quality one night before surgery
Measured: 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
Measured: 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
Measured: the third night after surgery
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian ClockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194866
- Sponsor's protocol ID
- circadian clock
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
- ClinicalTrials.gov ID
- NCT04194866
- Acronym / sponsor ID
- circadian clock
- Keywords
- circadian clock, postoperative cognitive function, general anesthesia, elderly patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day group | Other | Other: receiving operation during the day or at night60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group ( 8:00-12:00) |
| Night group | Other | Other: receiving operation during the day or at night60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- preoperative sleep disorders
- did not receive any preoperative chemoradiotherapy
- the duration of surgery ≧3 hours
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| receiving operation during the day or at night120 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 | Day group, Night group |
Primary outcome
postoperative sleep quality of one night before surgery
Time frame: one night before the surgery
use sleep monitor to test the sleep quality one night before surgery
postoperative sleep quality of first night after surgery
Time frame: the first night after surgery
use sleep monitor to test the sleep quality first night after surgery
postoperative sleep quality of third night after surgery
Time frame: the third night after surgery
use sleep monitor to test the sleep quality third night after surgery
4 secondary outcomes
Preoperative cognitive function test
Time frame: one day before surgery
Postoperative cognitive function test of 6 weeks after surgery
Time frame: 6 weeks after surgery
Postoperative cognitive function test of 1 year after surgery
Time frame: 1 year after surgery
Postoperative cognitive function test of 3 years after surgery
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junchao Zhu study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing receiving operation during the day or at night in people with Circadian Clock and Postoperative Cognitive Function, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junchao Zhu (18940257257 ext. 18940257257, zhujc@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative sleep quality of one night before surgery (time frame: one night before the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.