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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

    Procedure/Surgery

    (UFTCA)The researcher removed the endotracheal tube either immediately or within 1 hour of the end of the procedure.

  • conventional general anesthesia (CGA)

    Procedure/Surgery

    (CGA)The researcher not extubated at the end of the operation and were admitted to the ICU under anesthesia with an endotracheal tube.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Ultra-Fast-Track Cardiac Anesthesia(UFTCA)Experimental treatment 1 intervention
Group B: conventional general anesthesia (CGA)Other 1 intervention

Trial outcomes

Primary outcomes

1

tracheal tube extubation time

Time interval for tracheal extubation

Time frame
From the end of the operation to the removal of the tracheal tube,up to 3 days
2

ICU length of stay

Length of time participants stayed in the ICU

Time frame
From entry to exit from ICU,approximately 3 days
3

Post-operative hospitalization

Length of postoperative hospitalization

Time frame
From the end of surgery to discharge, approximately 1 week
4

Length of hospitalization

Length of time participants stayed in the hospital

Time frame
From admission to discharge, approximately 2 weeks

Secondary outcomes

1

Time from end of surgery to removal from operating room

Time from end of surgery to removal from operating room

Time frame
From end of surgery to removal from operating room, up to 1 hour
2

Intraoperative opioid dosages

Intraoperative dosage of sufentanil and remifentanil for induction and maintenance of anesthesia

Time frame
intraoperative
3

VAS score

minimum values:1 maximum values:10 higher scores mean a worse outcome

Time frame
72 hours post-surgery
4

Postoperative opioid dosage

Level of postoperative analgesia

Time frame
From the end of surgery to discharge,approximately 1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: