Cerebral Oxygen Saturation, Postoperative Cognitive Function
Conditions
Keywords
controlled hypotension
Brief summary
To observe whether adjusting the level of intraoperative controlled hypotension through cerebral oxygen saturation monitoring can improve postoperative cognitive function(POCD) and reduce postoperative neurological complications, a prospective randomized controlled study method will be used in this study. 400 elderly patients undergoing shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block will be selected. They will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.
Detailed description
Cognitive function will be evaluated within 3 days before operation and 3 days, 14 days and 3 months after operation. Delirium and VAS pain score will be evaluated 24 hours after operation. Venous blood will be taken before operation and 24 hours after operation to detect cognitive related markers and inflammatory factors. In addition, 10 blood samples of patients in each group were selected for RNA omics test. One month, six months and 12 months after operation, cognitive function was evaluated by cognitive function telephone questionnaire (TICS-M), and the ability of daily living was evaluated by IDAL. In addition, 20 non-surgical patients were selected for cognitive function evaluation at the same time point as the exercise effect of POCD detection.
Interventions
OTHERControlled hypotension guided by cerebral oxygen saturation monitoring
In this group, intraoperative monitoring of cerebral oxygen saturation will be used. When the cerebral oxygen saturation decreased by 20% \ 25% compared with the baseline for 300 seconds without improvement, or the cerebral oxygen saturation decreased by 25% \ 30% compared with the baseline for 180 seconds without improvement, intervention would be carried out. When the cerebral oxygen saturation decreased by 30% compared with the baseline, immediate intervention would be carried out. The intervention measures were intravenous administration of deoxyepinephrine 50 \ 100 μg or ephedrine 5 \ 10mg, which can be administered multiple times until the cerebral oxygen saturation reaches more than 80% of the baseline.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study, different researchers will be responsible for randomization, anesthesia and visit. A researcher is responsible for assigning random numbers to ensure the randomness of the study groups. Due to the intraoperative monitoring of cerebral oxygen saturation in the experimental group, it is impossible to blind the researchers implementing anesthesia. In order to ensure that the whole study is not affected by subjective factors, the visiting researchers are blinded, who do not know the anesthesia grouping, and are responsible for case enrollment screening, signing informed consent, preoperative and postoperative cognitive function evaluation, postoperative pain evaluation, complications and safety evaluation.
Intervention model description
Recruited patients will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring.
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block; * ASA grade ≤ grade III; * Patients Can communicate normally, can cooperate and complete cognitive function test; * Patients volunteered and signed informed consent.
Exclusion criteria
* BMI \< 18 or \> 27 kg / m2; * Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc; * Patients taking sedatives or antidepressants; * Alcoholics or drug addicts; * Illiteracy, severe hearing or visual impairment; * Patients with cognitive impairment before operation (MMSE score \< 23); * Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization; * Patients unable to carry out long-term follow-up or poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative cognitive dysfunction(POCD) 3 days after operation | 3 days after operation | The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative cognitive dysfunction(POCD) 14 days after operation | 14 days after operation | The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test. |
| Incidence of postoperative cognitive dysfunction(POCD) 3 months after operation | 3 months after operation | The Neuropsychological test, includes: (1) Vocabulary learning; (2) Vocabulary recall; (3) Connection test; (4) Stroop Color word interference; (5) Letter-number coding test. |
| Expression changes of cognitive function related markers 24 hours after operation | 24 hours after operation | Patients consented on blood sampling receive marker analysis from blood（S100β、NSE and IL-6). |
| Hospital expenses | through hospitalization period, an average of 15 day | Hospital expenses |
| Perioperative complications | 1 day (during the surgical period) | Complications during the surgical period |
| Hospital stay | through hospitalization period, an average of 15 day | Hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes | through study completion, an average of 1 year | Complications and adverse reactions of patients during the study period |
Outcome results
None listed