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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients with high-risk stroke (combined with 3 risk factors or more according to the stroke risk screening table)

• 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

• The ASA is rated as Class II or III

• Patients who underwent invasive arterial blood pressure monitoring before surgery signed informed consent

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
yejing Zhu, PHD
zhuyejing1983@126.com
+8618758096745
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 214
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital

This content was sourced from clinicaltrials.gov

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