Clinical trial NCT06711432: Different Intraoperative Blood Pressure Management on Postoperative Cognitive Function in Tumor Patients（PRECISION）
Official title: Effects of Different Intraoperative Blood Pressure Management Strategies on Postoperative Cognitive Function and Adverse Outcomes in Tumor Patients With High Risk Factors for Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor
Stroke
Keywords: blood pressure management strategies
postoperative cognitive function
tumor patients
high risk factors for stroke
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 214
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: After entering the operating room, invasive blood pressure, heart rate, electrocardiogram and SpO2 were monitored, central vein was opened, and intravenous administration of Sufentanil 0.3-0.5ug/kg, etomidate 0.3mg /kg and rocurobromide 0.9mg/kg were performed after induction of anesthesia. Mechanical ventilation, VT 6-8 mL/ kg, RR 12-16 times/min, PETCO2 3540mmHg maintained. Intraoperative continuous infusion of propofol and remifentanil to maintain Bis 40-60 (TCI or constant velocity?) . Do not use dexmedetomidine or benzodiazepines during anesthesia; Scopolamine and penehyclidine are also prohibited because they promote the occurrence of postoperative delirium. Atropine is only used to treat bradycardia when necessary. The MAP set threshold is maintained in the two groups of patients, below the threshold, as follows: 1. Administer reasonable vasoactive drugs, and record the dose; 2. Appropriate fluid infusion and body position changes are given and recorded; 3. Intraoperative blood gas analysis was monitored to maintain electrolyte homeostasis; 4. Once the hematocrit is less than 28%, give blood transfusion; 30 minutes before the end of surgery, 0.1-0.2ug/kg sufentanil was used as analgesic load. Peripheral nerve blocks, such as paravertebral block, transverse abdominal muscle plane block, etc., or combined epidural anesthesia are routinely performed.

Patients without contraindications were routinely given an NSAID-type drug combined with acetaminophen (acetaminophen 500mg or flurbiprofen 50mg or parexib 40mg) before incision. According to clinical routine infusion, blood transfusion/blood products if necessary, maintain urine volume \>0.5ml/kg/h, hemoglobin ≥8g/dL. During the operation, the nasopharyngeal temperature was maintained at 36-37C.

Treatment after operation: The patient was admitted to the postoperative recovery room (PACU) after the operation and recovery and extubation, or entered the PACU with tube; Routine monitoring includes non-invasive blood pressure, pulse oxygen saturation and electrocardiogram. Stay at PACU for at least 30 minutes and return to the ward after the modified Aldrete score is ≥9. Unstable patients are sent to the ICU after surgery.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative delirium and cognitive function in patients with high-risk stroke.
timeFrame: in one week after surgery
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 30 days after surgery.
Other outcomes:
measure: S100 calcium-binding protein B
timeFrame: on postoperative day 3 and one week after surgery
measure: BDNF
timeFrame: on postoperative day 3 and one week after surgery
measure: ubiquitin C-terminal hydrolase-L1 (UCH-L1)
timeFrame: on postoperative day 3 and one week after surgery
measure: neurofilament light chain protein (NfL)
timeFrame: on postoperative day 3 and one week after surgery
measure: cardiac troponin I
timeFrame: on postoperative day 3 and one week after surgery
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: