Multicentre Clinical Study of Ultra-Fast-Track Anaesthesia for Minimally Invasive Heart Valve Surgery
NCT Number: NCT06541483
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Valve Diseases|Enhanced Recovery After Surgery
Interventions: PROCEDURE: Ultra-Fast-Track Cardiac Anesthesia(UFTCA)|PROCEDURE: conventional general anesthesia (CGA)
Sponsor: Zhejiang Provincial People's Hospital
Collaborators: Beijing Anzhen Hospital|Fudan University|Wuhan Asia Heart Hospital|Tianjin Chest Hospital|Chinese PLA General Hospital|First Affiliated Hospital Xi'an Jiaotong University|Xiangya Hospital of Central South University|The Fourth Affiliated Hospital of Zhejiang University School of Medicine|Guangdong Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2028-12

Summary:
The goal of this clinical trial is to evaluate the clinical effects of ultra-fast-track anesthesia (UFTA) for minimally invasive cardiac surgery (MICS) in adults. It will also learn about the safety and feasibility of Ultra-Fast-Track cardiac surgery(UFTCA).The main questions it aims to answer are:Does UFTCA promote rapid postoperative recovery, reduce postoperative complications and perioperative mortality, and improve the quality of mid- and long-term survival.And does it improve patient satisfaction and reduce healthcare costs.

Participants will receive homogenized perioperative management in the cardiac ward, extracorporeal circulation, and postoperative ICU, except for anesthesia extubation time.Furthermore，Participants need complete quality of life scales at 30 days, 90 days, six months, and one year after surgery, separately.

Participants in this study are adults who required elective minimally invasive heart valve surgery under extracorporeal circulation.This study will be able to promote rapid recovery while reducing the associated costs and the financial burden on participants.Retrospective big data analysis of perioperative clinical characteristics of patients undergoing minimally invasive heart valve surgery to establish a risk warning model and develop a perioperative management program. The investigators then conducts a randomized group trial comparing the similarities and differences between conventional general anesthesia（CGA） and ultra-fast-track cardiac anesthesia(URTCA) to demonstrate the effectiveness and safety of UFTA in MICS.Finally, building expert consensus.

Primary Outcome Measures: tracheal tube extubation time, Time interval for tracheal extubation, From the end of the operation to the removal of the tracheal tube,up to 3 days|ICU length of stay, Length of time participants stayed in the ICU, From entry to exit from ICU,approximately 3 days|Post-operative hospitalization, Length of postoperative hospitalization, From the end of surgery to discharge, approximately 1 week|Length of hospitalization, Length of time participants stayed in the hospital, From admission to discharge, approximately 2 weeks|complication, Acute kidney injury, coma, acute respiratory distress syndrome (ARDS), postoperative atrial fibrillation, pericardial tamponade, gastrointestinal complications, death, cardiac arrest, heart block, and permanent stroke, From the end of surgery to 1 year after surgery|Unscheduled events, reintubation, reoperation,ICU readmission, 30-day readmission, From the end of surgery to 30 days after surgery|The 36-Item Short Form Health Survey(SF-36), minimum values:0 maximum values:100 higher scores mean a better outcome, up to 1 year postoperative|expenditure, Total cost of treatment, From admission to discharge, approximately 2 weeks
Secondary Outcome Measures: Time from end of surgery to removal from operating room, Time from end of surgery to removal from operating room, From end of surgery to removal from operating room, up to 1 hour|Intraoperative opioid dosages, Intraoperative dosage of sufentanil and remifentanil for induction and maintenance of anesthesia, intraoperative|VAS score, minimum values:1 maximum values:10 higher scores mean a worse outcome, 72 hours post-surgery|Postoperative opioid dosage, Level of postoperative analgesia, From the end of surgery to discharge,approximately 1 week|Application of vasoactive drugs, Vasoactive drugs given as per participant and intraoperative needs, intraoperative|oxygenation index, Pulmonary Function Assessment, From admission to discharge, approximately 2 weeks|Thoracic drainage within 24 hours, Thoracic drainage within 24 hours after surgery, 24 hours post-surgery|Total Thoracic Drainage, Total postoperative chest drainage, From the end of surgery to chest drain removal, approximately 3 days|Thoracic drain removal time, Thoracic drain removal time, From the end of surgery to chest drain removal, approximately 3 days|Bowel evacuation time, Assessment of postoperative recovery of gastrointestinal function, Time from end of surgery to first bowel evacuation, approximately 2 days|time out of bed, First time out of bed, Time from end of surgery to first time out of bed, approximately 2 days|Inflammatory levels, interleukin(IL)-1β,IL-4,IL-6,IL-8,IL-10,Procalcitonin(PCT),Hypersensitive C-reactive protein(hs-CRP) and tumor necrosis factor(TNF)-α, From the start of anesthesia induction to 48 hours after extubation|coagulation, Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Fibrinogen (FIB), D-dimer (DD2), Fibrin (Pro) Degradation Product (FDP), Antithrombin III (ATIII ), Thromboelastography (TEG), One day before to the next day after surgery,72 hours|myocardial injury, N-terminal Pro-brain B-type Natriuretic Peptides(NT-proBNP）, Cardiac troponin I(cTnI ), One day before to the next day after surgery,72 hours|neurological injury, Neuron-specific enolase(NSE), One day before to the next day after surgery,72 hours|Anesthesia costs, Costs incurred for perioperative anesthesia medications and anesthesia management requirements, Until 1 hours post-surgery|Patient satisfaction, Participants are rated on a 10-point satisfaction scale minimum values:1 maximum values:10 higher scores mean a better outcome, up to 1 year after discharge from hospital