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

NCT ID: NCT06711432

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-18
• Study Completion Date: 2026-06-01

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.

Conditions

Tumor; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Strict Blood Pressure Management Group (MAP > 80 mmHg)

Management strategy: For patients assigned to strict blood pressure management, stop taking ACEI (angiotensin converting enzyme inhibitors) or ARB (angiotensin receptor blockers) on the day of surgery. Other antihypertensive drugs can be given selectively depending on the patient's blood pressure level. Intraoperative use of norepinephrine or phenylephrine (norepinephrine 0.01-0.1μg/kg/min or phenylephrine 0.15-1.1 ug/kg/min). The actual infusion speed depends on achieving the target MAP.

Group Type: EXPERIMENTAL

Norepinephrine or phenylephrine

Intervention Type: DRUG

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).

Management strategy of the conventional blood pressure management group (MAP>65mmHg

For patients assigned to the conventional blood pressure management group, ACEI, ARB or calcium antagonists can be used until the morning of the day of surgery if the anesthesiologist deems it necessary. Intraoperative blood pressure management is based on routine, and it is not necessary to use pressor drugs prophylactically, which can be used according to the actual clinical situation. In general, intraoperative MAP should not be lower than 65mmHg. If there is no contraindication of hypotension, oral antihypertensive drugs can be resumed as soon as possible after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhu Yejing

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

yejing Zhu, PHD

Role: CONTACT

zhuyejing1983@126.com

+8618758096745

Facility Contacts

Yejing Zhu, PHD

Role: primary

zhuyj@zjcc.org.cn

+8618758096745

Other Identifiers

IRB-2024-556

Identifier Type: -

Identifier Source: org_study_id