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RECRUITINGINTERVENTIONAL

Different Intraoperative Blood Pressure Management on Postoperative Cognitive Function in Tumor Patients(PRECISION)

Effects of Different Intraoperative Blood Pressure Management Strategies on Postoperative Cognitive Function and Adverse Outcomes in Tumor Patients With High Risk Factors for Stroke

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a randomized controlled study to explore whether perioperative blood pressure management with different strategies can reduce the incidence of delirium and postoperative cognitive impairment and serious perfusion related complications (persistent hypotension, new heart arrhythmia, cardiac insufficiency, new stroke, sudden death, etc.) within 30 days after stroke in cancer patients at high risk for stroke. Patients were randomly divided into: 1) strict blood pressure management group: norepinephrine or phenylephrine maintenance intraoperative MAP≥85 mmHg, and 2) conventional blood pressure management group: intraoperative routine blood pressure management (MAP≥65mmHg). The study included 424 subjects and was randomized to provide 90% efficacy. Secondary markers were unscrupulous cerebrovascular events (persistent hypotension, arrhythmia, cardiac insufficiency, new stroke, sudden death) within 30 days after surgery.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with high-risk stroke (combined with 3 risk factors or more according to the stroke risk screening table) 2. Patients who plan to undergo surgery for abdominal tumors (gynecological, urinary, hepatobiliary, and gastrointestinal tumors) under general anesthesia are expected to have surgery duration \>2 hours 3. The ASA is rated as Class II or III 4. Patients who underwent invasive arterial blood pressure monitoring before surgery signed willing to sign a consent form Who Should NOT Join This Trial: 1. Patients do not want to participate in the study 2. Patients with severe heart disease (severe valvular disease, sick sinus syndrome, high atrioventricular block without pacemaker implantation), grade III or above Liver function impairment (Child-Pugh class C) 3. Need kidney replacement therapy; New stroke \<3 months 4. Emergency surgery 5. Preoperative history of mental illness, epilepsy, Parkinson's disease, or myasthenia gravis 6. Speech, vision, or hearing impairment that prevents completion of a cognitive function assessment 7. Situations where strict blood pressure management is not appropriate, such as controlled hypotension during surgery. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients with high-risk stroke (combined with 3 risk factors or more according to the stroke risk screening table) 2. Patients who plan to undergo surgery for abdominal tumors (gynecological, urinary, hepatobiliary, and gastrointestinal tumors) under general anesthesia are expected to have surgery duration \>2 hours 3. The ASA is rated as Class II or III 4. Patients who underwent invasive arterial blood pressure monitoring before surgery signed informed consent Exclusion Criteria: 1. Patients do not want to participate in the study 2. Patients with severe heart disease (severe valvular disease, sick sinus syndrome, high atrioventricular block without pacemaker implantation), grade III or above Liver function impairment (Child-Pugh class C) 3. Need kidney replacement therapy; New stroke \<3 months 4. Emergency surgery 5. Preoperative history of mental illness, epilepsy, Parkinson's disease, or myasthenia gravis 6. Speech, vision, or hearing impairment that prevents completion of a cognitive function assessment 7. Situations where strict blood pressure management is not appropriate, such as controlled hypotension during surgery.

Treatments Being Tested

DRUG

Norepinephrine or phenylephrine

Intraoperative use of norepinephrine or phenylephrine (norepinephrine 0.01-0.1ug/kg/min, or phenylephrine 0.15-1.1 ug/kg/min). The actual infusion speed depends on reaching the target MAP(\>=80mmHg).

Locations (1)

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China