About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Controlled hypotension guided by cerebral oxygen saturation monitoring
Other interventionIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative cognitive dysfunction(POCD) 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 outcomes
Incidence of postoperative cognitive dysfunction(POCD) 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
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
Patients consented on blood sampling receive marker analysis from blood(S100β、NSE and IL-6).
Hospital stay
Hospital stay
Other outcomes
Safety outcomes
Complications and adverse reactions of patients during the study period
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: