TumorPRECISIONNCT06711432
Different Intraoperative Blood Pressure Management on Postoperative Cognitive Function in Tumor Patients（PRECISION）
A study testing Norepinephrine or phenylephrine in people with Tumor and Stroke, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- What is being tested?
- Norepinephrine or phenylephrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yejing Zhu, PHD, +8618758096745, zhuyj@zjcc.org.cn
About this study
Official 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
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.
Read the 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 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.
- Being tested
- Norepinephrine or phenylephrine
- Keywords
- blood pressure management strategies, postoperative cognitive function, tumor patients, high risk factors for stroke
- Medical subject headings
- Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine or phenylephrineDrug
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 group | Role | What they receive |
|---|---|---|
| Strict Blood Pressure Management Group (MAP > 80 mmHg) | Experimental | 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. Receives: Drug: Norepinephrine or phenylephrine |
| Management strategy of the conventional blood pressure management group (MAP>65mmHg | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium and cognitive function in patients with high-risk stroke.
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.
Measured: in one week after surgery
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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.
Measured: 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start18 Sep 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Yejing, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711432
- Sponsor's protocol ID
- IRB-2024-556
- Acronym
- PRECISION
- Status last verified
- Nov 2024
- First submitted
- 10 Aug 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06711432
- Acronym / sponsor ID
- PRECISION / IRB-2024-556
- Keywords
- blood pressure management strategies, postoperative cognitive function, tumor patients, high risk factors for stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict Blood Pressure Management Group (MAP > 80 mmHg) | Experimental | Drug: 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. |
| Management strategy of the conventional blood pressure management group (MAP>65mmHg | No intervention | –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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norepinephrine or phenylephrineIntraoperative 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). | Drug | Strict Blood Pressure Management Group (MAP > 80 mmHg) |
Primary outcome
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.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine or phenylephrine in people with Tumor and Stroke, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yejing Zhu, PHD (+8618758096745, zhuyejing1983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium and cognitive function in patients with high-risk stroke. (time frame: in one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.