Clinical trial NCT05341531: Relationship Between Perioperative Related Factors and Inflammatory Markers and Postoperative Delirium in Elderly Patients With Non-cardiac Major Surgery
Official title: Relationship Between Perioperative Related Factors and Inflammatory Markers and Postoperative Delirium in Elderly Patients With Non-cardiac Major Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Sleep Disorder
Preoperative Anxiety
Inflammatory Reaction
Postoperative Delirium
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients 60 years and older undergoing major non-cardiac surgery \> 2 hours

Brief 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 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 .


Eligibility criteria: Inclusion Criteria:

* ①patients over 60 years old;

  * ASA grade II-IV;

    * major surgery for \>2 hours,

      * hospital stay \>2 days.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Perioperative cognitive function
timeFrame: one day before surgery
measure: Perioperative cognitive function
timeFrame: first day after surgery
measure: Perioperative cognitive function
timeFrame: third day after surgery
measure: Perioperative cognitive function
timeFrame: one week after surgery
measure: Perioperative cognitive function
timeFrame: 30 days after surgery
measure: Perioperative cognitive function
timeFrame: 1 year after surgery
measure: preoperative sleep quality
timeFrame: 24 hours before surgery
measure: postoperative sleep quality
timeFrame: first day after surgery
measure: postoperative sleep quality
timeFrame: third day after surgery
measure: preoperative anxiety
timeFrame: one day before surgery
Secondary outcomes:
measure: patients characteristics
timeFrame: one day before surgery
measure: surgery characteristics
timeFrame: during the surgery
measure: perioperative inflammatory markers: systemic inflammation index (SII)
timeFrame: baseline before surgery
measure: perioperative inflammatory markers: systemic inflammation index (SII)
timeFrame: first day after surgery
measure: perioperative inflammatory markers: systemic inflammation index (SII)
timeFrame: third day after surgery
measure: perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
timeFrame: baseline before surgery
measure: perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
timeFrame: first day after surgery
measure: perioperative inflammatory markers: neutrophil-to-lymphocyte ratio (NLR)
timeFrame: third day after surgery
measure: perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
timeFrame: baseline before surgery
measure: perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
timeFrame: first day after surgery
measure: perioperative inflammatory markers: monocyte-to-lymphocyte ratio (MLR)
timeFrame: third day after surgery
measure: perioperative inflammatory markers: c-reactive protein ( CRP)
timeFrame: baseline before surgery
measure: perioperative inflammatory markers: c-reactive protein ( CRP)
timeFrame: first day after surgery
measure: perioperative inflammatory markers: c-reactive protein ( CRP)
timeFrame: third day after surgery
Other outcomes:
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