ERAS
Conditions
Keywords
ERAS, Cardiac surgery
Brief summary
The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.
Detailed description
The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.
Interventions
OTHERPreoperative Strategies
Patient Education Preoperative Oral Carbohydrate Loading Nutritional Optimization Glycemic Control Anemia Correction Preoperative Hair Removal
OTHERIntraoperative Strategies
Anesthetic Technique (Multimodal Analgesia) Antibiotics Glycemic Control Blood Transfusion Blood Conservation Optimization of Hemodynamics Protective Lung Ventilation Strategy Optimization of Anesthetic Depth Optimization of CPB Management
OTHERPostoperative Strategies
Postoperative Analgesia Temperature Management Renal Protection Glycemic Control Early Extubation Early Oral Intake Maintain Drain Patency and Early Removal Early Ambulation Thromboprophylaxis
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 80 years. * Undergoing elective surgery. * Scheduled for cardiac valve surgery with cardiopulmonary bypass. * Body mass index (BMI) between 16.5 and 31 kg/m². * American Society of Anesthesiologists (ASA) physical status classification of II or III.
Exclusion criteria
* Refusal to participate, refusal to sign the informed consent form, or inability to communicate. * Participation in other clinical trials concurrently. * Combined coronary artery bypass grafting or ascending aorta surgery. * Emergency surgery. * Active infective endocarditis. * Previous history of cardiac surgery. * Preoperative presence of neurocognitive disorders (NCD), depression, or other psychiatric conditions. * Known abuse of alcohol, drugs, or anesthetics. * Pregnant or breastfeeding women. * Presence of other serious comorbidities that may impede enrollment or affect survival, such as malignancies or severe disabilities. Termination of Intervention Intervention will be terminated for the following reasons: * Withdrawal of consent and request to exit the trial during the study period. * Significant changes in surgical approach: including the addition of deep hypothermic circulatory arrest, intra-aortic balloon counterpulsation (IABP) support, extracorporeal membrane oxygenation (ECMO) support, etc. * Medical necessity for termination of intervention, as determined by the investigator, for example: use of cardiopulmonary bypass more than twice during surgery; unexpected difficulties in weaning from cardiopulmonary bypass or extubation; continued treatment may pose a risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay | Within 1 month after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation after surgery | Within 1 week after surgery | — |
| Postoperative bowel motility | within 1 month after surgery | — |
| Overall hospitalization costs | Within 3 months after surgery | — |
| Transfusion requirements | within 1 month after surgery | — |
| Length of ICU stay | Within 1 month after surgery | — |
| Quality of recovery | within 1 month after surgery | assessed using the 15-item Quality of Recovery-15 (QoR-15) scale, with each item scored from 0 (very poor) to 10 (very good), for a total score of 150 |
| Chronic pain | within 6 months after surgery | Diagnostic Criteria of Chronic (postsurgical) Pain 1. Chronic pain (persistent or recurrent for longer than 3 months) is present. 2. The pain began or increased in intensity after surgery. 3. The pain is in an area of preceding surgery. 4. The pain persisted for at least 3 months after the initiating event. 5. The pain is not better accounted for by an infection, a malignancy, a pre-existing pain condition or any other alternative |
| Patient's subjective comfort | within 6 months after surgery | assessed using the Bruggrmann Comfort Scale (BCS)，it is a scoring tool for assessing patient comfort, ranging from 0 (persistent pain) to 4 (pain-free even when coughing) |
| Postoperative complications | within 6 months after surgery | Including mortality and complications both in-hospital and post-discharge |
| Postoperative acute pain | within 1 month after surgery | assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain) |
Countries
China
Outcome results
None listed