Coronary Artery Disease, Postoperative Complications
Conditions
Keywords
Off-Pump Coronary Artery Bypass Grafting, Blood Pressure Management, Mean Arterial Pressure, Remimazolam, Propofol, Postoperative Complications
Brief 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. 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.
Interventions
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.
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.
DRUGRemimazolam
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.
DRUGPropofol
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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Scheduled for elective, isolated, primary OPCAB under general anaesthesia; 3. Agree to complete the baseline assessments and postoperative follow-up required by the study protocol.
Exclusion criteria
1. Known allergy to remimazolam, benzodiazepines, propofol, etomidate, sufentanil, cisatracurium; 2. Pregnancy or breastfeeding; 3. Life expectancy \<30 days because of a noncardiac condition; 4. Severe cognitive, language, hearing, visual, or communication impairment precluding completion of the required CAM/CAM-ICU or MoCA assessments; 5. 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; 6. Maintenance hemodialysis or peritoneal dialysis; 7. Delirium at the preoperative baseline assessment; 8. Concurrent participation in another interventional clinical trial that could interfere with the study interventions or outcome assessment; 9. Other condition considered by the investigator to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the 30-Day Composite of Postoperative Complications or All-Cause Mortality | From postoperative day 1 through postoperative day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Delirium | From postoperative day 1 through postoperative day 7 | — |
| Incidence of Cognitive Decline | At postoperative day 7 and postoperative day 30 | — |
| Incidence of Stroke | From postoperative day 1 through postoperative day 30 | — |
| Incidence of Cardiac Complications | From postoperative day 1 through postoperative day 30 | — |
| Incidence of Respiratory Failure | From postoperative day 1 through postoperative day 30 | — |
| Incidence of Severe Acute Kidney Injury | From postoperative day 1 through postoperative day 7 | — |
| Incidence of Infectious Complications | From postoperative day 1 through postoperative day 30 | — |
| All-Cause Mortality | Within 30 days after surgery | — |
| Incidence of Intraoperative Hypotension | From the start of maintenance anesthesia until completion of surgery | — |
| Time-Weighted Average Below 0.80 × T0 Mean Arterial Pressure | From the start of maintenance anesthesia until completion of surgery | — |
| Incidence of Intraoperative Hypertension | From the start of maintenance anesthesia until completion of surgery | — |
| Incidence of Intraoperative Bradycardia | From the start of maintenance anesthesia until completion of surgery | — |
| Incidence of Intraoperative Tachycardia | From the start of maintenance anesthesia until completion of surgery | — |
| Time-Weighted Mean of the MAP/HR Ratio | From the start of maintenance anesthesia until completion of surgery | — |
| Incidence of Major Hemodynamic Rescue Interventions | From induction of anesthesia until completion of surgery | — |
| Incidence of Acute Kidney Injury of Any Stage | Within 7 days after surgery | — |
| Incidence of New-Onset Atrial Fibrillation | Within 30 days after surgery | — |
| Incidence of Postoperative Pulmonary Complications | Within 30 days after surgery | — |
| Incidence of Unplanned Reoperation or Reintervention | Within 30 days after surgery | — |
| Incidence of Unplanned Hospital Readmission | Within 30 days after surgery | — |
| Duration of Mechanical Ventilation | At extubation, approximately 12 hours after surgery | — |
| Intensive Care Unit Length of Stay | At ICU discharge, an average of 3 days | — |
| Postoperative Hospital Length of Stay | At hospital discharge, an average of 7 days | — |
| Incidence of Prespecified Anesthetic-Related Safety Events | Through hospital discharge, approximately 7 days after surgery | — |
| Change in Plasma Phosphorylated Tau 217 Concentration | From the preoperative baseline through postoperative day 3 | — |
| Change in Plasma Neurofilament Light Chain Concentration | From the preoperative baseline through postoperative day 3 | — |
| Change in Plasma Glial Fibrillary Acidic Protein Concentration | From the preoperative baseline through postoperative day 3 | — |
| Cumulative Incidence of the Long-Term Composite Clinical Outcome | At 6 and 12 months after surgery | — |
| Telephone Montreal Cognitive Assessment Score | 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. |
Outcome results
None listed