Preoperative Sleep DisorderNCT05341531
Relationship Between Perioperative Related Factors and Inflammatory Markers and Postoperative Delirium in Elderly Patients With Non-cardiac Major Surgery
An observational study of Preoperative Sleep Disorder and Preoperative Anxiety, run by Beijing Friendship Hospital.
Trial summary
Perioperative neurocognitive impairment, including postoperative delirium (POD), is common in older patients after anesthesia and surgery and is associated with poorer short- and long-term outcomes, including worsening cognitive decline, surgical Complications, increased risk of hospitalization, and death after… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Preoperative Sleep Disorder, Preoperative Anxiety, Inflammatory Reaction
- What is being tested?
- elderly patients undergoing non-cardiac surgery
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Observational
- 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 60 to 100 years
- All sexes
- Adult, Older adult
Study population: Elderly patients 60 years and older undergoing major non-cardiac surgery > 2 hours
Who may be able to join
- ①patients over 60 years old;
- ASA grade II-IV;
- major surgery for >2 hours,
- hospital stay >2 days.
Who cannot join
- ①History of neurological, cerebral or psychiatric diseases;
- History of alcoholism or drug dependence;
- Preoperative delirium, or previous postoperative delirium; ④No obvious visual, auditory, and communication impairment;
- No obvious liver and kidney Functional impairment; ⑥ The surgical site interferes with BIS electrode placement;
- Planned wake-up test during the surgery; ⑧ No follow-up is expected after 1 year.
About this study
Perioperative neurocognitive impairment, including postoperative delirium (POD), is common in older patients after anesthesia and surgery and is associated with poorer short- and long-term outcomes, including worsening cognitive decline, surgical Complications, increased risk of hospitalization, and death after cardiac and noncardiac surgery. POD is more common with age, occurs in up to 65% of elderly patients, and increases in patients with mild cognitive impairment. As more and more older adults undergo surgery and anesthesia, POD has become a major global health challenge requiring urgent attention. Prevention strategies involving multidisciplinary perioperative interventions may have some benefit overall, but the impact on POD remains uncertain. Known inflammatory responses may be associated with adverse outcomes such as neurocognitive dysfunction and cancer recurrence after major surgery. Different anesthesia methods, the regulation of anesthesia drugs on postoperative inflammatory response has been confirmed in vitro, but its clinical significance is still unclear. Therefore, exploring the risk factors of inducing POD has important clinical significance for the early prevention of POD. Second, a recent study found that the incidence of POD was significantly higher in patients whose sleep cycle was disturbed during hospitalization. Animal experiments found that after 5 hours of sleep deprivation in adult mice, the number of dendritic spines in CA1 neurons in the hippocampus was reduced, and the length of dendrites was significantly shortened, which damaged the synaptic transmission of the central nervous system, and significantly improved memory and cognitive function. Damaged. And many studies have investigated whether bispectral index (BIS)-guided anesthesia is associated with a reduced risk of POD, compared with "standard-of-care" anesthesia or the use of goal-directed end-tidal volatile agent concentrations, the reasoning is that the use of BIS-guided anesthesia results in less anesthesia exposure, and therefore "light" anesthesia may reduce the incidence of postoperative POD compared to "deep" anesthesia. However, this conclusion is still controversial. The study of Anshentong et al. has confirmed that deep anesthesia with BIS maintained at 40-49 can delay postoperative recovery time, reduce the level of inflammatory factors and the incidence of early postoperative cognitive impairment, and reduce the incidence of early postoperative cognitive impairment. Brain damage. Therefore, although age is known to be the main correlative factor for POD, different depths of anesthesia may cause different stress responses in patients, resulting in different release of inflammatory factors. An additional risk factor may be preoperative psychiatric symptoms, and assessment of mental status is often overshadowed by concerns about multiple comorbidities in older adults. Anxiety disorders are one of the prominent psychiatric symptoms in older adults. very common. Preoperative anxiety is defined as an unpleasant restless or tense state secondary to patient concerns about illness, hospitalization, anesthesia, surgery, or the unknown. Studies on the relationship between preoperative anxiety and POD also vary in consistency due to the characteristics of different populations. Many of the current studies are mostly single-center with limited sample size, which may have a certain bias in the conclusions. Therefore, the investigators designed and planned to conduct a multi-center, large-sample cohort study to determine the impact of perioperative related factors and inflammatory markers on elderly patients undergoing non-cardiac major surgery .
- Conditions
- Preoperative Sleep Disorder, Preoperative Anxiety, Inflammatory Reaction, Postoperative Delirium
- Being tested
- elderly patients undergoing non-cardiac surgery
- Medical subject headings
- Inflammation, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elderly patients undergoing non-cardiac surgeryOther
Elderly patients 60 years and older undergoing major non-cardiac surgery > 2 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative cognitive function
The Mini Mental Scale (MMSE) assessed cognitive function at baseline. The evaluation items of MMSE include: location, attention, computing ability of asking time and place, immediate recall ability of short-term review language, and graph reproduction ability. The test is conducted in the way of asking questions. The scale score ranges from 0 to 30 points, and the final score is 27-30 points, which can be regarded as normal. If the score is less than 27 points, it can be regarded as cognitive impairment.
Measured: one day before surgery
Perioperative cognitive function
The Confusion Assessment Method (CAM) assessed cognitive function on the first day after surgery.
Measured: first day after surgery
Perioperative cognitive function
The Confusion Assessment Method (CAM) assessed cognitive function on the third day after surgery.
Measured: third day after surgery
Perioperative cognitive function
The Confusion Assessment Method (CAM) assessed cognitive function on the day of discharge
Measured: one week after surgery
Perioperative cognitive function
Minimal Telephone Scale (AMTS) assessed cognitive function at 30 days after surgery, and 1 year after surgery, respectively. Scores 6 or below have been shown to correlate well with dementia.
Measured: 30 days after surgery
Perioperative cognitive function
Minimal Telephone Scale (AMTS) assessed cognitive function at 30 days after surgery, and 1 year after surgery, respectively. Scores 6 or below have been shown to correlate well with dementia.
Measured: 1 year after surgery
preoperative sleep quality
The Pittsburgh Sleep Quality Index (PSQI) scale was used to evaluate the patient's sleep status 24 hours before surgery for sleep quality during the past month.The Pittsburgh sleep quality index was assessed by 19 self-rated questions and 5 sleep peers problem composition. Only 19 self-rated questions were scored. The 19 self-assessment questions consist of 7 of 03 points. A factor. "0" means no difficulty and "3" means very difficult. All factors are added to form 021. Total score of the scale. "0" means no difficulty and "21" means very difficulty in all aspects
Measured: 24 hours before surgery
postoperative sleep quality
Postoperative sleep scores were recorded using the Athens Insomnia Scale (AIS). 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
Measured: first day after surgery
postoperative sleep quality
Postoperative sleep scores were recorded using the Athens Insomnia Scale (AIS). 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
Measured: third day after surgery
preoperative anxiety
The preoperative anxiety level was assessed by the Hans Anxiety Scale (HADS) before the operation. 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
Measured: one day before surgery
Secondary outcomes (14)
patients characteristics
Record the patient's characteristics before surgery
Measured: one day before surgery
surgery characteristics
Record the patient's surgery characteristics during operation
Measured: during the surgery
perioperative inflammatory markers: systemic inflammation index (SII)
SII=platelet count×neutrophil count/lymphocyte count
Measured: baseline before surgery
perioperative inflammatory markers: systemic inflammation index (SII)
SII=platelet count×neutrophil count/lymphocyte count
Measured: first day after surgery
perioperative inflammatory markers: systemic inflammation index (SII)
SII=platelet count×neutrophil count/lymphocyte count
Measured: third day after surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
NLR=neutrophil count/lymphocyte count
Measured: baseline before surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
NLR=neutrophil count/lymphocyte count
Measured: first day after surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
NLR=neutrophil count/lymphocyte count
Measured: third day after surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
MLR=monocyte count/lymphocyte count
Measured: baseline before surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
MLR=monocyte count/lymphocyte count
Measured: first day after surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
MLR=monocyte count/lymphocyte count
Measured: third day after surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
markers: c-reactive protein ( CRP)
Measured: baseline before surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
markers: c-reactive protein ( CRP)
Measured: first day after surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
markers: c-reactive protein ( CRP)
Measured: third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bijia Song, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341531
- Sponsor's protocol ID
- Risk factors and delirium
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 22 Apr 2022
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Perioperative Related Factors and Inflammatory Markers and Postoperative Delirium in Elderly Patients With Non-cardiac Major Surgery
- ClinicalTrials.gov ID
- NCT05341531
- Acronym / sponsor ID
- Risk factors and delirium
- Conditions
- Preoperative Sleep Disorder, Preoperative Anxiety, Inflammatory Reaction, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Apr 2022 (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.
Perioperative neurocognitive impairment, including postoperative delirium (POD), is common in older patients after anesthesia and surgery and is associated with poorer short- and long-term outcomes, including worsening cognitive decline, surgical Complications, increased risk of hospitalization, and death after cardiac and noncardiac surgery. POD is more common with age, occurs in up to 65% of elderly patients, and increases in patients with mild cognitive impairment. As more and more older adults undergo surgery and anesthesia, POD has become a major global health challenge requiring urgent attention. Prevention strategies involving multidisciplinary perioperative interventions may have some benefit overall, but the impact on POD remains uncertain. Known inflammatory responses may be associated with adverse outcomes such as neurocognitive dysfunction and cancer recurrence after major surgery. Different anesthesia methods, the regulation of anesthesia drugs on postoperative inflammatory response has been confirmed in vitro, but its clinical significance is still unclear. Therefore, exploring the risk factors of inducing POD has important clinical significance for the early prevention of POD. Second, a recent study found that the incidence of POD was significantly higher in patients whose sleep cycle was disturbed during hospitalization. Animal experiments found that after 5 hours of sleep deprivation in adult mice, the number of dendritic spines in CA1 neurons in the hippocampus was reduced, and the length of dendrites was significantly shortened, which damaged the synaptic transmission of the central nervous system, and significantly improved memory and cognitive function. Damaged. And many studies have investigated whether bispectral index (BIS)-guided anesthesia is associated with a reduced risk of POD, compared with "standard-of-care" anesthesia or the use of goal-directed end-tidal volatile agent concentrations, the reasoning is that the use of BIS-guided anesthesia results in less anesthesia exposure, and therefore "light" anesthesia may reduce the incidence of postoperative POD compared to "deep" anesthesia. However, this conclusion is still controversial. The study of Anshentong et al. has confirmed that deep anesthesia with BIS maintained at 40-49 can delay postoperative recovery time, reduce the level of inflammatory factors and the incidence of early postoperative cognitive impairment, and reduce the incidence of early postoperative cognitive impairment. Brain damage. Therefore, although age is known to be the main correlative factor for POD, different depths of anesthesia may cause different stress responses in patients, resulting in different release of inflammatory factors. An additional risk factor may be preoperative psychiatric symptoms, and assessment of mental status is often overshadowed by concerns about multiple comorbidities in older adults. Anxiety disorders are one of the prominent psychiatric symptoms in older adults. very common. Preoperative anxiety is defined as an unpleasant restless or tense state secondary to patient concerns about illness, hospitalization, anesthesia, surgery, or the unknown. Studies on the relationship between preoperative anxiety and POD also vary in consistency due to the characteristics of different populations. Many of the current studies are mostly single-center with limited sample size, which may have a certain bias in the conclusions. Therefore, the investigators designed and planned to conduct a multi-center, large-sample cohort study to determine the impact of perioperative related factors and inflammatory markers on elderly patients undergoing non-cardiac major surgery .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elderly patients 60 years and older undergoing major non-cardiac surgery > 2 hours
Key inclusion criteria (4 listed)
- ①patients over 60 years old;
Key exclusion criteria (5 listed)
- ①History of neurological, cerebral or psychiatric diseases;
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 |
|---|---|---|
| elderly patients undergoing non-cardiac surgeryElderly patients 60 years and older undergoing major non-cardiac surgery > 2 hours | Other | – |
Primary outcome
Perioperative cognitive function
Time frame: one day before surgery
The Mini Mental Scale (MMSE) assessed cognitive function at baseline. The evaluation items of MMSE include: location, attention, computing ability of asking time and place, immediate recall ability of short-term review language, and graph reproduction ability. The test is conducted in the way of asking questions. The scale score ranges from 0 to 30 points, and the final score is 27-30 points, which can be regarded as normal. If the score is less than 27 points, it can be regarded as cognitive impairment.
Perioperative cognitive function
Time frame: first day after surgery
The Confusion Assessment Method (CAM) assessed cognitive function on the first day after surgery.
Perioperative cognitive function
Time frame: third day after surgery
The Confusion Assessment Method (CAM) assessed cognitive function on the third day after surgery.
Perioperative cognitive function
Time frame: one week after surgery
The Confusion Assessment Method (CAM) assessed cognitive function on the day of discharge
Perioperative cognitive function
Time frame: 30 days after surgery
Minimal Telephone Scale (AMTS) assessed cognitive function at 30 days after surgery, and 1 year after surgery, respectively. Scores 6 or below have been shown to correlate well with dementia.
Perioperative cognitive function
Time frame: 1 year after surgery
Minimal Telephone Scale (AMTS) assessed cognitive function at 30 days after surgery, and 1 year after surgery, respectively. Scores 6 or below have been shown to correlate well with dementia.
preoperative sleep quality
Time frame: 24 hours before surgery
The Pittsburgh Sleep Quality Index (PSQI) scale was used to evaluate the patient's sleep status 24 hours before surgery for sleep quality during the past month.The Pittsburgh sleep quality index was assessed by 19 self-rated questions and 5 sleep peers problem composition. Only 19 self-rated questions were scored. The 19 self-assessment questions consist of 7 of 03 points. A factor. "0" means no difficulty and "3" means very difficult. All factors are added to form 021. Total score of the scale. "0" means no difficulty and "21" means very difficulty in all aspects
postoperative sleep quality
Time frame: first day after surgery
Postoperative sleep scores were recorded using the Athens Insomnia Scale (AIS). 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
postoperative sleep quality
Time frame: third day after surgery
Postoperative sleep scores were recorded using the Athens Insomnia Scale (AIS). 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
preoperative anxiety
Time frame: one day before surgery
The preoperative anxiety level was assessed by the Hans Anxiety Scale (HADS) before the operation. 0-3 means no insomnia 4-6 means suspected insomnia. >6 insomnia
14 secondary outcomes
patients characteristics
Time frame: one day before surgery
surgery characteristics
Time frame: during the surgery
perioperative inflammatory markers: systemic inflammation index (SII)
Time frame: baseline before surgery
perioperative inflammatory markers: systemic inflammation index (SII)
Time frame: first day after surgery
perioperative inflammatory markers: systemic inflammation index (SII)
Time frame: third day after surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
Time frame: baseline before surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
Time frame: first day after surgery
perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
Time frame: third day after surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
Time frame: baseline before surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
Time frame: first day after surgery
perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
Time frame: third day after surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
Time frame: baseline before surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
Time frame: first day after surgery
perioperative inflammatory markers: c-reactive protein ( CRP)
Time frame: third day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Sleep Disorder and Preoperative Anxiety, run by Beijing Friendship Hospital.
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 4 inclusion and 5 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative cognitive function (time frame: one day before surgery). The study lists 10 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 22 Apr 2022.