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Clinical Trials in China / NCT06711432
Recruiting Not applicable

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

NCT06711432 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang Cancer Hospital
Phase
Not applicable
Started
2024-09-18
Last updated
2024-12-02

Condition(s) studied

TumorStroke

Investigational drug(s) / intervention(s)

Norepinephrine or phenylephrine

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).

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Zhejiang Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06711432 on ClinicalTrials.gov ↗ ← All trials in China