Managing blood pressure during surgery to improve cognitive function in cancer patients
Effects of Different Intraoperative Blood Pressure Management Strategies on Postoperative Cognitive Function and Adverse Outcomes in Tumor Patients With High Risk Factors for Stroke
This study is testing if keeping blood pressure at a higher level during surgery can help cancer patients think better and avoid confusion after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06711432 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study investigates the effects of different intraoperative blood pressure management strategies on postoperative cognitive function in cancer patients at high risk for stroke. Participants are divided into two groups: one receiving strict blood pressure management to maintain a mean arterial pressure (MAP) of at least 85 mmHg, and the other following conventional management with a MAP of at least 65 mmHg. The study aims to reduce the incidence of delirium and cognitive impairment, as well as serious complications related to blood pressure fluctuations within 30 days post-surgery. A total of 424 subjects are included to ensure robust statistical power.
Who should consider this trial
Good fit: Ideal candidates are cancer patients with multiple risk factors for stroke who are scheduled for abdominal surgeries lasting over two hours.
Not a fit: Patients with severe heart disease, recent strokes, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cognitive impairment and serious complications in high-risk cancer patients undergoing surgery.
How similar studies have performed: While similar approaches have been explored, this specific strategy of blood pressure management in high-risk cancer patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: yejing Zhu, PHD
- Email: zhuyejing1983@126.com
- Phone: +8618758096745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.