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

N/ANot Yet RecruitingNCT07787364

Chinese Academy of Medical Sciences, Fuwai Hospital416 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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