Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02843152 |
| Other study ID # |
14038789 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
June 25, 2016 |
| Last updated |
July 20, 2016 |
| Start date |
May 2015 |
| Est. completion date |
September 2016 |
Study information
| Verified date |
July 2016 |
| Source |
Xuzhou Medical College |
| Contact |
dengji wang |
| Phone |
+8618761420798 |
| Email |
574658525[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
China: Food and Drug Administration |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This study use Loewenstein cognitive function rating scale to meet the standards of the
elderly cognitive function assessment. POCD diagnostic criteria used is the recommended
value Z current international law, in order to reduce the effects of exercise, we selected
50 cases of patients with age-matched healthy control group as a spouse, the same scale
testing. And Loewenstein Assessment Scale cognitive function after some domestic research
proved to have good sensitivity, and easy to test small changes in cognitive ability.
Before the investigation began strict inclusion and exclusion criteria, the use of simple
intelligence scale exclude preoperative cognitive decline in the elderly significantly, the
use of depression rating scale for anxiety rating scale before surgery to exclude severe
depression and severe anxiety in elderly self self patient. Testing by the same person in
the same way neurocognitive assessment test twice, 7 days apart.
Studies in Chinese population, susceptibility SNPs and genetic POCD but there are few
reports of this project uses 1: 1 matched case-control study, by comparison POCD SNPs and
control groups of different polymorphisms, polymorphisms Discussion Han population of
postoperative cognitive dysfunction associated with susceptibility to find Chinese Han
population of postoperative cognitive disorders genetic susceptibility markers, which
provide scientific screening and early diagnosis of postoperative cognitive impairment at
high risk in accordance with
Description:
1. study 1.1 The study inclusion criteria: The study in January 2015 - June 2015 Xuzhou
Medical College Hospital orthopedic ward in elderly patients, level of education for
primary ((0
1.2 study exclusion criteria: Severe vision (1) no history of cerebrovascular disease
(2) Other medical history (3) No alcohol dependence and other substance abuse history
(4) to cause central nervous system damage did not affect cognitive function can not
affect cognitive tests, hearing and limb movement disorder (5) without mental illness
(6) Exclude known preoperative cognitive dysfunction (7) can not articulate the
patient's own meaning or do not match, the patient can not communicate very well.
In contrast to cases by sex and age and frequency matching. Study subjects were Chinese
Han population, and signed informed consent form, a collection of peripheral blood
specimens (5mlEDTA anticoagulated blood). At the same time, by specially trained
investigators to complete the epidemiological survey.
2. field epidemiology survey methodology 2.1 Questionnaire items (perioperative
observations Indicator) 2.1.1 Preoperative: gender, age, education, past medical
history (hypertension, diabetes, chronic lung disease), surgery.
2.1.2 Surgery: The operation time, the number of anesthesia, fentanyl, remifentanil, the
dosage of atropine, hypotension, hypertension. Intraoperative hypotension cases: surgery or
any time SBP≤90 mm Hg compared with preoperative blood pressure reduced by more than 30% for
longer than 5min; intraoperative hypertension cases: surgery any time SBP≥140 / 90mmHg or
comparing preoperative more than 30% increase in blood pressure over the duration of 5min.
2.1.3 Postoperative: Postoperative 7d or prior to discharge using a visual analog scale
(vasual analogue scale, VAS) to assess the degree of pain the patient and postoperative
complications were recorded (with or without infection, reoperation).
2.2 neuropsychological assessment tools: 2.2.1 Simple Intelligence Scale (Mini-Mental State
Examination, MMSE) 2.2.2 Self-Rating Depression Scale (Self-Rating Depression Scale, SDS)
2.2.3 Self-Rating Anxiety Scale (Self-Rating Anxiety Scale SAS) 2.3.4 know Abilities
Screening Instrument 2.3 postoperative cognitive dysfunction assessment program and
criteria: POCD for assessment, the project recommended using the current Z value of
international law, in order to reduce the effects of exercise, selected 50 cases of patients
with age-matched healthy control group as a spouse, the same scale test, the exclusion
criteria with the control group. POCD is calculated as: Z = (X-X reference) / SD .. X is a
preoperative patient surgery, the score of the difference, X reference is the difference
between the scale scores before and after the control group, SD is the standard deviation of
the difference between the control group. When the Z value of the test in two or more scale
test is greater than 1.96 is considered POCD.
Answers were recorded accurately complete the test score or the time required. MMSE scale is
mainly used for screening in elderly subjects, excluding preoperative cognitive function in
patients with significantly decreased. Self-Rating Depression Scale suitable for different
age, gender patients with depression score. Self-Rating Anxiety Scale suitable for different
age, gender patients' anxiety before surgery to evaluate anxiety and depression status,
excluding severe anxiety and depression survey, no longer be evaluated cognitive abilities.
In addition, we selected 50 cases of patients with age-matched healthy control group as a
spouse, learn to reduce the effects of neuropsychological tests before the subject later.
Testing by the same person in the same way neurocognitive assessments, test twice, 7 days
apart. Loewenstein cognitive function using standard rating scale for the assessment of
cognitive function in older people. Loewenstein cognitive neuropsychological rating scale is
Luria and Piaget's developmental model is based, including the time and place orientation,
visual perception, spatial perception, action apply, depending on the sports organization,
logical thinking, attention and concentration, assessment the project was more than MMSE,
and a detailed breakdown can not only reflect the patient's cognitive problems in these
areas, but also to predict the progress of change and prognosis of brain injury, a more
appropriate amount is used to assess postoperative cognitive impairment table.
In this study, an international research organization POCD recommended Z-score method to
determine the incidence of postoperative cognitive dysfunction, and is divided into POCD and
control groups. To analyze the effect of learning, healthy control subjects before and after
the calculation of each individual test item score difference, the difference between the
results of mean and standard deviation, and then calculated for each patient before and
after surgery score difference between the individual test items, use When this difference
is divided by the standard deviation that is obtained by subtracting the mean of each
individual test item Z-score, Z score greater the greater the decline after the test scores
compared with preoperative. Each individual test items Z summing points, healthy control
subjects Z points and calculate the standard deviation S, each patient divided by the S and
Z-score is the composite of the patient's Z-score, if the composite Z-score ≥21.96
individual tests or have two or more Z-score greater than or equal 96, it is considered that
the patients POCD. Orthopedic patients in the control group from the same period, the age
and gender of the patient group want to match.
2.4 survey items related definitions 2.4.1 alcohol. Drinking 2 years and above, equivalent
to an ethanol content of women ≥20 g / d, male ≥40 g / d.
2.4.2 Hypertension. Are receiving antihypertensive medications, or past medical history of
diagnosed hypertension, or in patients with more than 2 times extraordinary Systolic ≥140
mmH; and (or) DBP) 90 mmHg} 2.4.3 diabetes. Taking hypoglycemic drugs, or a previous
diagnosis of diabetes or fasting glucose measurement ≥7.0 mmol / L, random blood glucose
≥11.1 mmol / L.
2.4.4 TNM staging. Use appropriate staging of the disease 2.4.5 intraoperative hypotension.
A reduction in blood pressure than before anesthesia or 20% less than 80 mmHg systolic 2.4.6
postoperative continuous analgesia. Surgery received intravenous analgesia pump, intravenous
analgesia with fentanyl as postoperative analgesics, loading dose of 0.5μg / kg, background
dosage 0. 3μg / (kg • h), a single dose of 0.25μg / kg , lockout time 15 min, time 48 h.
