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NCT Number: NCT06711432

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location status: Recruiting

Location contact

Yejing Zhu, PHD

CONTACT

[email protected]

+8618758096745

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients do not want to participate in the study
  • 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)
  • Need kidney replacement therapy; New stroke <3 months
  • Emergency surgery
  • Preoperative history of mental illness, epilepsy, Parkinson's disease, or myasthenia gravis
  • Speech, vision, or hearing impairment that prevents completion of a cognitive function assessment
  • Situations where strict blood pressure management is not appropriate, such as controlled hypotension during surgery.

Treatment and study plan

Norepinephrine or phenylephrine

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).

Primary outcomes

  1. Postoperative delirium and cognitive function in patients with high-risk stroke.

    Time frame: 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 assessed by trained researchers (non-anesthesia personnel) who conduct cognitive tests. If a patient experiences an acute change or fluctuation in their mental state, decreased attention, confusion of thought, or a change in level of consciousness, then delirium is present. If delirium requires intervention, the patient receives an intravenous injection of haloperidol, and if necessary, it is repeated every 60 minutes and recorded promptly.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 30 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) postoperative survival status.

Other outcomes

  1. S100 calcium-binding protein B

    Time frame: on postoperative day 3 and one week after surgery

    S100B was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions.

  2. BDNF

    Time frame: on postoperative day 3 and one week after surgery

    BDNF was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions.

  3. ubiquitin C-terminal hydrolase-L1 (UCH-L1)

    Time frame: on postoperative day 3 and one week after surgery

    UCH-L1 was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions.

  4. neurofilament light chain protein (NfL)

    Time frame: on postoperative day 3 and one week after surgery

    NfL was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions.

  5. cardiac troponin I

    Time frame: on postoperative day 3 and one week after surgery

    cardiac troponin I was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck & Co Inc, USA) according to manufacturer's instructions.

Study contacts

Contact information is provided by the study sponsor or research team.

yejing Zhu, PHD

CONTACT

[email protected]

+8618758096745

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Acronym: PRECISION

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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