Coronary Artery DiseaseNCT07787364
Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
A study testing Targeted Blood Pressure Management, Liberal Blood Pressure Management and Remimazolam in people with Coronary Artery Disease and Postoperative Complications, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
The goal of this clinical trial is to learn whether two approaches to anesthesia and blood pressure management can improve care for adults having off-pump coronary artery bypass grafting (OPCAB). OPCAB is a type of heart bypass surgery performed without routinely using a heart-lung machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Postoperative Complications
- What is being tested?
- Targeted Blood Pressure Management, Liberal Blood Pressure Management and Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 31 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Scheduled for elective, isolated, primary OPCAB under general anaesthesia;
- Agree to complete the baseline assessments and postoperative follow-up required by the study protocol.
Who cannot join
- Known allergy to remimazolam, benzodiazepines, propofol, etomidate, sufentanil, cisatracurium;
- Pregnancy or breastfeeding;
- Life expectancy <30 days because of a noncardiac condition;
- Severe cognitive, language, hearing, visual, or communication impairment precluding completion of the required CAM/CAM-ICU or MoCA assessments;
- Preoperative AKI within 7 days before surgery, defined by any Kidney Disease: Improving Global Outcomes (KDIGO) criterion: an increase in serum creatinine of ≥0.3 mg∙dL-1 (≥26.5 µmol∙L-1) within 48 hours; an increase to ≥1.5 times a known or presumed baseline value within 7 days; or urine output <0.5 mL∙kg-1∙hour-1 for at least 6 hours;
- Maintenance hemodialysis or peritoneal dialysis;
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- Delirium at the preoperative baseline assessment;
- Concurrent participation in another interventional clinical trial that could interfere with the study interventions or outcome assessment;
- Other condition considered by the investigator to make participation inappropriate.
About this study
Official title: Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: a Study Protocol for a Prospective, Single-centre, Randomized, Controlled Trial
The goal of this clinical trial is to learn whether two approaches to anesthesia and blood pressure management can improve care for adults having off-pump coronary artery bypass grafting (OPCAB). OPCAB is a type of heart bypass surgery performed without routinely using a heart-lung machine.
The main questions this study aims to answer are:
Read more
- Does keeping mean arterial pressure (MAP), a measure of average blood pressure, at 65 mm Hg or higher during surgery lower the chance of major complications or death within 30 days after surgery compared with usual clinician-directed blood pressure management?
- Does remimazolam provide more stable blood pressure and heart rate than propofol when used to maintain general anesthesia during surgery?
The researchers expect that targeted blood pressure management may lower the chance of major postoperative complications. They also expect that remimazolam may provide more stable blood pressure and heart rate than propofol.
Researchers plan to enroll 416 adults having elective OPCAB surgery. Participants will be randomly assigned to one of four groups. Each group will receive one of two blood pressure strategies and one of two medicines for maintaining general anesthesia.
Participants will:
- Receive either targeted blood pressure management or usual clinician-directed blood pressure management during surgery.
- Receive either remimazolam or propofol to maintain general anesthesia after the same standard anesthesia induction.
- Have routine monitoring during surgery and assessments during recovery after surgery.
- Complete follow-up assessments after surgery, including assessments of complications, recovery, and longer-term health. Some participants will also provide blood samples for a biomarker substudy.
The study will also explore whether the effect of the blood pressure strategy differs depending on which anesthetic medicine is used.
- Being tested
- Targeted Blood Pressure Management, Liberal Blood Pressure Management, Remimazolam, Propofol
- Keywords
- Off-Pump Coronary Artery Bypass Grafting, Blood Pressure Management, Mean Arterial Pressure, Remimazolam, Propofol, Postoperative Complications
- Medical subject headings
- Coronary Artery Disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Blood Pressure ManagementOther
Mean arterial pressure (MAP) will be maintained at 65 mm Hg or higher from induction of anesthesia until completion of surgery. A confirmed MAP below 65 mm Hg will prompt verification of the arterial pressure measurement and treatment directed at the presumed clinical cause. Treatment may include fluids, blood products, vasopressors, inotropes, heart-rate or rhythm management, cardiac repositioning, temporary pacing, or mechanical circulatory support when clinically indicated.
Liberal Blood Pressure ManagementOther
No trial-mandated mean arterial pressure target or study-defined treatment threshold will be imposed. Blood pressure will be managed at the discretion of the attending anesthesiologist according to usual clinical practice, the participant's clinical condition, and surgical conditions. Rescue treatment will be unrestricted when required for participant safety.
RemimazolamDrug
Remimazolam will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg/kg/hour and may be titrated within 0.5-1.5 mg/kg/hour according to clinical requirements. The infusion will be discontinued at completion of skin closure.
PropofolDrug
Propofol will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg/kg/hour and may be titrated within 0.5-1.5 mg/kg/hour according to clinical requirements. The infusion will be discontinued at completion of skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Targeted BP Management + Remimazolam | Experimental | Not described Receives: Other: Targeted Blood Pressure Management; Drug: Remimazolam |
| Targeted BP Management + Propofol | Experimental | Not described Receives: Other: Targeted Blood Pressure Management; Drug: Propofol |
| Liberal BP Management + Remimazolam | Experimental | Not described Receives: Other: Liberal Blood Pressure Management; Drug: Remimazolam |
| Liberal BP Management + Propofol | Experimental | Not described Receives: Other: Liberal Blood Pressure Management; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality
Measured: From postoperative day 1 through postoperative day 30
Secondary outcomes (29)
Incidence of Postoperative Delirium
Measured: From postoperative day 1 through postoperative day 7
Incidence of Cognitive Decline
Measured: At postoperative day 7 and postoperative day 30
Incidence of Stroke
Measured: From postoperative day 1 through postoperative day 30
Incidence of Cardiac Complications
Measured: From postoperative day 1 through postoperative day 30
Incidence of Respiratory Failure
Measured: From postoperative day 1 through postoperative day 30
Incidence of Severe Acute Kidney Injury
Measured: From postoperative day 1 through postoperative day 7
Incidence of Infectious Complications
Measured: From postoperative day 1 through postoperative day 30
All-Cause Mortality
Measured: Within 30 days after surgery
Incidence of Intraoperative Hypotension
Measured: From the start of maintenance anesthesia until completion of surgery
Time-Weighted Average Below 0.80 × T0 Mean Arterial Pressure
Measured: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Hypertension
Measured: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Bradycardia
Measured: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Tachycardia
Measured: From the start of maintenance anesthesia until completion of surgery
Time-Weighted Mean of the MAP/HR Ratio
Measured: From the start of maintenance anesthesia until completion of surgery
Incidence of Major Hemodynamic Rescue Interventions
Measured: From induction of anesthesia until completion of surgery
Incidence of Acute Kidney Injury of Any Stage
Measured: Within 7 days after surgery
Incidence of New-Onset Atrial Fibrillation
Measured: Within 30 days after surgery
Incidence of Postoperative Pulmonary Complications
Measured: Within 30 days after surgery
Incidence of Unplanned Reoperation or Reintervention
Measured: Within 30 days after surgery
Incidence of Unplanned Hospital Readmission
Measured: Within 30 days after surgery
Duration of Mechanical Ventilation
Measured: At extubation, approximately 12 hours after surgery
Intensive Care Unit Length of Stay
Measured: At ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Measured: At hospital discharge, an average of 7 days
Incidence of Prespecified Anesthetic-Related Safety Events
Measured: Through hospital discharge, approximately 7 days after surgery
Change in Plasma Phosphorylated Tau 217 Concentration
Measured: From the preoperative baseline through postoperative day 3
Change in Plasma Neurofilament Light Chain Concentration
Measured: From the preoperative baseline through postoperative day 3
Change in Plasma Glial Fibrillary Acidic Protein Concentration
Measured: From the preoperative baseline through postoperative day 3
Cumulative Incidence of the Long-Term Composite Clinical Outcome
Measured: At 6 and 12 months after surgery
Telephone Montreal Cognitive Assessment Score
Cognitive function will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA). Scores range from 0 to 22, with higher scores indicating better cognitive function.
Measured: At 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexin Liu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787364
- Sponsor's protocol ID
- FW-BP-Remi-2026
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: a Study Protocol for a Prospective, Single-centre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07787364
- Acronym / sponsor ID
- FW-BP-Remi-2026
- Keywords
- Off-Pump Coronary Artery Bypass Grafting, Blood Pressure Management, Mean Arterial Pressure, Remimazolam, Propofol, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 Aug 2026 (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.
The goal of this clinical trial is to learn whether two approaches to anesthesia and blood pressure management can improve care for adults having off-pump coronary artery bypass grafting (OPCAB). OPCAB is a type of heart bypass surgery performed without routinely using a heart-lung machine.
The main questions this study aims to answer are:
- Does keeping mean arterial pressure (MAP), a measure of average blood pressure, at 65 mm Hg or higher during surgery lower the chance of major complications or death within 30 days after surgery compared with usual clinician-directed blood pressure management?
- Does remimazolam provide more stable blood pressure and heart rate than propofol when used to maintain general anesthesia during surgery?
The researchers expect that targeted blood pressure management may lower the chance of major postoperative complications. They also expect that remimazolam may provide more stable blood pressure and heart rate than propofol.
Researchers plan to enroll 416 adults having elective OPCAB surgery. Participants will be randomly assigned to one of four groups. Each group will receive one of two blood pressure strategies and one of two medicines for maintaining general anesthesia.
Participants will:
- Receive either targeted blood pressure management or usual clinician-directed blood pressure management during surgery.
- Receive either remimazolam or propofol to maintain general anesthesia after the same standard anesthesia induction.
- Have routine monitoring during surgery and assessments during recovery after surgery.
- Complete follow-up assessments after surgery, including assessments of complications, recovery, and longer-term health. Some participants will also provide blood samples for a biomarker substudy.
The study will also explore whether the effect of the blood pressure strategy differs depending on which anesthetic medicine is used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Targeted BP Management + Remimazolam | Experimental | Other: Targeted Blood Pressure Management, Drug: Remimazolam |
| Targeted BP Management + Propofol | Experimental | Other: Targeted Blood Pressure Management, Drug: Propofol |
| Liberal BP Management + Remimazolam | Experimental | Other: Liberal Blood Pressure Management, Drug: Remimazolam |
| Liberal BP Management + Propofol | Experimental | Other: Liberal Blood Pressure Management, Drug: Propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years;
- Scheduled for elective, isolated, primary OPCAB under general anaesthesia;
- Agree to complete the baseline assessments and postoperative follow-up required by the study protocol.
Key exclusion criteria (9 listed)
- Known allergy to remimazolam, benzodiazepines, propofol, etomidate, sufentanil, cisatracurium;
- Pregnancy or breastfeeding;
- Life expectancy <30 days because of a noncardiac condition;
- Severe cognitive, language, hearing, visual, or communication impairment precluding completion of the required CAM/CAM-ICU or MoCA assessments;
- Preoperative AKI within 7 days before surgery, defined by any Kidney Disease: Improving Global Outcomes (KDIGO) criterion: an increase in serum creatinine of ≥0.3 mg∙dL-1 (≥26.5 µmol∙L-1) within 48 hours; an increase to ≥1.5 times a known or presumed baseline value within 7 days; or urine output <0.5 mL∙kg-1∙hour-1 for at least 6 hours;
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 |
|---|---|---|
| Targeted Blood Pressure ManagementMean arterial pressure (MAP) will be maintained at 65 mm Hg or higher from induction of anesthesia until completion of surgery. A confirmed MAP below 65 mm Hg will prompt verification of the arterial pressure measurement and treatment directed at the presumed clinical cause. Treatment may include fluids, blood products, vasopressors, inotropes, heart-rate or rhythm management, cardiac repositioning, temporary pacing, or mechanical circulatory support when clinically indicated. | Other | Targeted BP Management + Propofol, Targeted BP Management + Remimazolam |
| Liberal Blood Pressure ManagementNo trial-mandated mean arterial pressure target or study-defined treatment threshold will be imposed. Blood pressure will be managed at the discretion of the attending anesthesiologist according to usual clinical practice, the participant's clinical condition, and surgical conditions. Rescue treatment will be unrestricted when required for participant safety. | Other | Liberal BP Management + Propofol, Liberal BP Management + Remimazolam |
| RemimazolamRemimazolam will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg/kg/hour and may be titrated within 0.5-1.5 mg/kg/hour according to clinical requirements. The infusion will be discontinued at completion of skin closure. | Drug | Liberal BP Management + Remimazolam, Targeted BP Management + Remimazolam |
| PropofolPropofol will be administered by continuous intravenous infusion for maintenance of general anesthesia beginning immediately after internal jugular vein catheterization. The initial infusion rate will be 1.0 mg/kg/hour and may be titrated within 0.5-1.5 mg/kg/hour according to clinical requirements. The infusion will be discontinued at completion of skin closure. | Drug | Liberal BP Management + Propofol, Targeted BP Management + Propofol |
Primary outcome
Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality
Time frame: From postoperative day 1 through postoperative day 30
29 secondary outcomes
Incidence of Postoperative Delirium
Time frame: From postoperative day 1 through postoperative day 7
Incidence of Cognitive Decline
Time frame: At postoperative day 7 and postoperative day 30
Incidence of Stroke
Time frame: From postoperative day 1 through postoperative day 30
Incidence of Cardiac Complications
Time frame: From postoperative day 1 through postoperative day 30
Incidence of Respiratory Failure
Time frame: From postoperative day 1 through postoperative day 30
Incidence of Severe Acute Kidney Injury
Time frame: From postoperative day 1 through postoperative day 7
Incidence of Infectious Complications
Time frame: From postoperative day 1 through postoperative day 30
All-Cause Mortality
Time frame: Within 30 days after surgery
Incidence of Intraoperative Hypotension
Time frame: From the start of maintenance anesthesia until completion of surgery
Time-Weighted Average Below 0.80 × T0 Mean Arterial Pressure
Time frame: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Hypertension
Time frame: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Bradycardia
Time frame: From the start of maintenance anesthesia until completion of surgery
Incidence of Intraoperative Tachycardia
Time frame: From the start of maintenance anesthesia until completion of surgery
Time-Weighted Mean of the MAP/HR Ratio
Time frame: From the start of maintenance anesthesia until completion of surgery
Incidence of Major Hemodynamic Rescue Interventions
Time frame: From induction of anesthesia until completion of surgery
Incidence of Acute Kidney Injury of Any Stage
Time frame: Within 7 days after surgery
Incidence of New-Onset Atrial Fibrillation
Time frame: Within 30 days after surgery
Incidence of Postoperative Pulmonary Complications
Time frame: Within 30 days after surgery
Incidence of Unplanned Reoperation or Reintervention
Time frame: Within 30 days after surgery
Incidence of Unplanned Hospital Readmission
Time frame: Within 30 days after surgery
Duration of Mechanical Ventilation
Time frame: At extubation, approximately 12 hours after surgery
Intensive Care Unit Length of Stay
Time frame: At ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Time frame: At hospital discharge, an average of 7 days
Incidence of Prespecified Anesthetic-Related Safety Events
Time frame: Through hospital discharge, approximately 7 days after surgery
Change in Plasma Phosphorylated Tau 217 Concentration
Time frame: From the preoperative baseline through postoperative day 3
Change in Plasma Neurofilament Light Chain Concentration
Time frame: From the preoperative baseline through postoperative day 3
Change in Plasma Glial Fibrillary Acidic Protein Concentration
Time frame: From the preoperative baseline through postoperative day 3
Cumulative Incidence of the Long-Term Composite Clinical Outcome
Time frame: At 6 and 12 months after surgery
Telephone Montreal Cognitive Assessment Score
Time frame: At 6 and 12 months 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 26 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Blood Pressure Management, Liberal Blood Pressure Management and Remimazolam in people with Coronary Artery Disease and Postoperative Complications, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality (time frame: From postoperative day 1 through postoperative day 30). 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 26 Aug 2026.