Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-79
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Controlled hypotension guided by cerebral oxygen saturation monitoring

    Other intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 days after operation

Secondary outcomes

1

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.

Time frame
14 days after operation
2

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.

Time frame
3 months after operation
3

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).

Time frame
24 hours after operation
4

Hospital stay

Hospital stay

Time frame
through hospitalization period, an average of 15 day

Other outcomes

1

Safety outcomes

Complications and adverse reactions of patients during the study period

Time frame
through study completion, an average of 1 year

Locations

This trial has no locations.

Sponsors and contacts

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