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

Not Applicable
Recruiting
Conditions
Interventions
Registration Number
NCT06711432
Lead Sponsor
Zhejiang Cancer Hospital
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 ...

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 35...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
214
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Strict Blood Pressure Management Group (MAP > 80 mmHg)Norepinephrine or phenylephrineManagement 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.
Primary Outcome Measures
NameTimeMethod
Postoperative delirium and cognitive function in patients with high-risk stroke.in one week after surgery

We use the Consciousness Ambiguity Measure (CAM) for POD assessment at 3, 5, and 7 days postoperatively. The 3-Minute Confusion Assessment Measure (3D-CAM) is used for POD assessment at 3, 5, and 7 days postoperatively, and the Memory Confusion Assessment Scale (MDAS) is used for POD severity scoring. Scores are taken twice, at 10:00 am and 5:00 pm, and are ...

Secondary Outcome Measures
NameTimeMethod
Number of participants with treatment-related adverse events as assessed by CTCAE v4.030 days after surgery.

Adverse cardiovascular events within 30 days after surgery were recorded: Such as persistent hypotension, arrhythmia, heart failure, and new strokes. Record the incidence of complications (new conditions that require medical intervention) within 30 days after surgery (including the hospitalization period) (follow-up by phone for discharged patients) postoper...

Trial Locations

Locations (1)

Zhejiang Cancer Hospital

🇨🇳

Hangzhou, Zhejiang, China

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