Multicentre Clinical Study of Ultra-Fast-Track Anaesthesia for Minimally Invasive Heart Valve Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 and ≤80 years

American Society of Anaesthesiologists (ASA) class I-III

New York Heart Association (NYHA) cardiac class III or below

Preoperative inspired air pulse oximetry (SpO2) ≥95%

Disqualifiers

Patient's refusal to participate

Severe communication disorders

Severe disorders of coagulation with spontaneous bleeding tendency

Long-term application of opioid analgesics

Trial design

Treatments tested in this trial

  • Ultra-Fast-Track Cardiac Anesthesia(UFTCA)
  • conventional general anesthesia (CGA)

Treatment groups

1,200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Zhejiang Provincial People's Hospital

Lead sponsor

Beijing Anzhen Hospital

Collaborator

Fudan University

Collaborator

Wuhan Asia Heart Hospital

Collaborator

Tianjin Chest Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Xiangya Hospital of Central South University

Collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborator

Guangdong Provincial People's Hospital

Collaborator