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NCT Number: NCT07787364

Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Targeted blood pressure management

Other

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 Management

Other

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.

Remimazolam

Drug

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.

Propofol

Drug

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.

Primary outcomes

  1. Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality

    Time frame: From postoperative day 1 through postoperative day 30

Secondary outcomes

  1. Incidence of Postoperative Delirium

    Time frame: From postoperative day 1 through postoperative day 7

  2. Incidence of Cognitive Decline

    Time frame: At postoperative day 7 and postoperative day 30

  3. Incidence of Stroke

    Time frame: From postoperative day 1 through postoperative day 30

  4. Incidence of Cardiac Complications

    Time frame: From postoperative day 1 through postoperative day 30

  5. Incidence of Respiratory Failure

    Time frame: From postoperative day 1 through postoperative day 30

  6. Incidence of Severe Acute Kidney Injury

    Time frame: From postoperative day 1 through postoperative day 7

  7. Incidence of Infectious Complications

    Time frame: From postoperative day 1 through postoperative day 30

  8. All-Cause Mortality

    Time frame: Within 30 days after surgery

  9. Incidence of Intraoperative Hypotension

    Time frame: From the start of maintenance anesthesia until completion of surgery

  10. Time-Weighted Average Below 0.80 × T0 Mean Arterial Pressure

    Time frame: From the start of maintenance anesthesia until completion of surgery

  11. Incidence of Intraoperative Hypertension

    Time frame: From the start of maintenance anesthesia until completion of surgery

  12. Incidence of Intraoperative Bradycardia

    Time frame: From the start of maintenance anesthesia until completion of surgery

  13. Incidence of Intraoperative Tachycardia

    Time frame: From the start of maintenance anesthesia until completion of surgery

  14. Time-Weighted Mean of the MAP/HR Ratio

    Time frame: From the start of maintenance anesthesia until completion of surgery

  15. Incidence of Major Hemodynamic Rescue Interventions

    Time frame: From induction of anesthesia until completion of surgery

  16. Incidence of Acute Kidney Injury of Any Stage

    Time frame: Within 7 days after surgery

  17. Incidence of New-Onset Atrial Fibrillation

    Time frame: Within 30 days after surgery

  18. Incidence of Postoperative Pulmonary Complications

    Time frame: Within 30 days after surgery

  19. Incidence of Unplanned Reoperation or Reintervention

    Time frame: Within 30 days after surgery

  20. Incidence of Unplanned Hospital Readmission

    Time frame: Within 30 days after surgery

  21. Duration of Mechanical Ventilation

    Time frame: At extubation, approximately 12 hours after surgery

  22. Intensive Care Unit Length of Stay

    Time frame: At ICU discharge, an average of 3 days

  23. Postoperative Hospital Length of Stay

    Time frame: At hospital discharge, an average of 7 days

  24. Incidence of Prespecified Anesthetic-Related Safety Events

    Time frame: Through hospital discharge, approximately 7 days after surgery

  25. Change in Plasma Phosphorylated Tau 217 Concentration

    Time frame: From the preoperative baseline through postoperative day 3

  26. Change in Plasma Neurofilament Light Chain Concentration

    Time frame: From the preoperative baseline through postoperative day 3

  27. Change in Plasma Glial Fibrillary Acidic Protein Concentration

    Time frame: From the preoperative baseline through postoperative day 3

  28. Cumulative Incidence of the Long-Term Composite Clinical Outcome

    Time frame: At 6 and 12 months after surgery

  29. Telephone Montreal Cognitive Assessment Score

    Time frame: At 6 and 12 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

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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