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

NCT ID: NCT06541483

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

This study was divided into two parts:The first part is retrospective data collection and organization, screening risk factors to establish an early warning model to improve the perioperative management program, and the other part is conducted using a randomized controlled trial to evaluate the effectiveness, safety and benefit of the perioperative management program of ultra-fast-track anesthesia(UFTA) for minimally invasive heart valve surgery. The specific program is as follows:

Part I

1. Establishment of an information collection platform Log in to the platform for electronic data entry and retain the paper version of the CaseReportForm（CRF）

2. Retrospective data collection Relying on the National Head Medical Center for Cardiac Surgery, 5000 perioperative case data of minimally invasive heart valve surgery patients were counted to obtain the perioperative clinical characteristics of Chinese adult minimally invasive heart valve surgery patients.

3. Screening for risk factors Statistical analysis of risk factors affecting perioperative ultra-fast-track anesthesia delivery and postoperative complications

4. Establishment of early warning model Combining age stratification, surgical mode stratification and general characteristics, establish an early warning model to improve the perioperative management protocol of ultra-fast channel anesthesia for minimally invasive heart valve surgery.

Part II Recruitment of participants for a prospective randomized controlled trial

1. Participants Patients undergoing elective minimally invasive adult heart valve surgery will be selected after completion of history taking, physical examination, preoperative laboratory and ancillary investigations, preoperative health and quality of life questionnaires, and frailty assessment of their physical condition, and will be confirmed to be free of any one of the "Exclusion Criteria" and to meet any one or more of the "Inclusion Criteria". Those who fulfill any one of the "Exclusion Criteria" and more than one of the "Inclusion Criteria" will be given a screening number. After completing the basic information and preoperative medications, the participant signed the informed consent form. If either the participant or the family member does not agree to participate in the study, the participant will only be given a screening number and the study will end here.

2. Randomized grouping Participants who were included to meet the criteria were randomly divided into the ultra-fast-track anesthesia group (UFTCA) and the conventional general anesthesia group (CGA), and the homogenized perioperative management of the extracardiac ward, extracorporeal circulation, and postoperative ICU was implemented, except for anesthesia resuscitation methods.

3. Anesthesia management 3.1 Preoperative Preoperative education, nutritional support, fasting and abstinence from food and drink, prophylactic multimodal analgesia (preoperative oral pregabalin 150 mg and acetaminophen 1000 mg) 3.2 Intraoperative Anesthesia mode: tracheal intubation general anesthesia plus nerve block anesthesia Induction of anesthesia: intravenous slow push etomidate fat milk injection 0.15 mg/kg, propofol injection 0.5~1.0 mg/kg, sufentanil citrate injection 0.4~0.5 mg/kg, rocuronium bromide 0.6~0.8 mg/kg, to be the patient's consciousness disappeared, to be the mask pressurized denitrification of oxygen for 3~5 minutes, muscle relaxation after the complete effect of the laryngoscopy under the direct visualization The patient was intubated, fixed, and mechanically ventilated, and the respiratory parameters were set as follows: Fraction of inspiratory oxygen concentration (FiO2): 50~80%, tidal volume (VT): 6~8 ml/kg, respiratory rate (RR): 10~12 times/min, Inhalation-exhalation ratio (I:E): 1:2, Maintain End-tidal CarbonDioxidePartialPressure (PetCO2) at 35~45 mmHg.

Anesthesia maintenance: Propofol injection 150~250 μg/(kg·min) and remifentanil 0.2~0.4 μg/(kg·min) were continuously pumped through the central venous catheter, and intraoperative EEG Bispectral Index (BIS) values were maintained between 40~60.

According to the hemodynamic indexes, respiratory parameters and the needs of surgical operation, intravenous sufentanil was injected in divided doses of 0.1~0.2 μg/kg, and the total amount of intraoperative sufentanil was controlled to be 1.0~1.5 μg/kg.

Additional rocuronium bromide 0.1~0.2 mg/kg was added at the time of aortic blockade and opening, respectively.

Intraoperative multimodal analgesia: (Pectoral nerves I(Pecs I), Pectoral nerves II(Pecs II), anterior serratus plane block(SPB)) anesthetic resuscitation: Evaluate to confirm whether the patient can be included in ultra-fast-track anesthesia.

After the aorta was opened, the anesthesiologist, by observing the surgical procedure and communicating with the surgeon as well as the sonographer in a timely manner, confirmed that the surgery was successful, the heart was restarting normally, the extracorporeal circulation was withdrawn smoothly, there was no active hemorrhage in the surgical field, hemostasis was complete, oxygenation was functioning well, and the patient's finger pulse oximetry saturation was ≥98% under conditions of inhaled pure oxygen.

UFTCA:The amount of propofol maintenance was dynamically adjusted according to the degree of stimulation at the beginning of chest closure, and all intravenous anesthesia maintenance drugs were discontinued at the beginning of chest closure. When the patient is under deep anesthesia, clear the patient's airway secretions and other foreign objects in advance; without interfering with the surgeon's operation, give bilateral lung bulging, and according to the trend of the BIS value and the patient's somatic reaction or not, give a single intravenous injection of propofol of 20~30mg as appropriate to maintain the patient's sedation until the end of the operation, and then remove the airway catheter when the patient is fully awake on the operating table. If necessary, an appropriate amount of neostigmine methylsulfate 1mg and atropine sulfate injection 0.5mg can be used intravenously to antagonize the muscle relaxant.

CGA:Propofol injection 150~250 μg/(kg·min) and remifentanil 0.2~0.4 ug/(kg·min) were continuously pumped, and the patients were transferred to the ICU with tubes, and the ICU doctors decided the timing of stopping sedation and extubation.

3.3 Postoperative multimodal analgesia Immediately after surgery, an intravenous analgesic pump was connected (sufentanil 200 μg and palonosetron 0.25 mg saline configured to a total of 200 mL)

4. Surgery Valve surgery encompasses aortic valve / mitral valve / tricuspid valve disease, performing single / double / triple valves, using minimally invasive procedures.This can be done through a small upper sternal incision, a small right anterior chest incision or a small transaxillary incision.

5. Extracorporeal circulation management The pre-filled fluid for extracorporeal circulation was 500~750 ml of crystalloid, 150 ml of 20% mannitol, 100 ml of 20% albumin, and 150 ml of sodium bicarbonate.

Heparinization was performed at 3~4 mg/kg, and extracorporeal circulation was started after activated clotting time(ACT)>480s. The pacing fluid and dosage was 30 ml/kg, and the total amount did not exceed 2000 ml.

During extracorporeal circulation, the mean arterial pressure was maintained at 50~80 mmHg, and the perfusion flow rate was 2.2~2.4 L/m^2.

6. Postoperative monitoring The Visual Analogue Score (VAS) was used for pain assessment after tracheal tube removal. VAS pain score by the nurse every 4 hours, if VAS ≥ 3, then press the analgesic pump once additional sufentanil 3 ~ 5 μg, 3 minutes later to assess again, if the patient VAS ≥ 3, then press the analgesic pump again additional sufentanil 3 ~ 5 μg; if sufentanil reached the analgesic pump set the limit of the amount of VAS ≥ 3 or produce serious nausea and vomiting and other side effects, then the intravenous oxycodone 10mg / time for Remedial analgesia.

Conditions

Heart Valve Diseases; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

The researchers implemented an ultra-fast-track anesthesia protocol, and the tracheal tube was removed immediately or within 1 hour of awakening at the end of the operation.

Group Type: EXPERIMENTAL

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

Intervention Type: PROCEDURE

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

conventional general anesthesia (CGA)

The researcher implemented a conventional anesthesia protocol, and participants were not extubated at the end of the procedure and were admitted to the ICU under anesthesia with an endotracheal tube.

Group Type: OTHER

conventional general anesthesia (CGA)

Intervention Type: PROCEDURE

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

Interventions

Ultra-Fast-Track Cardiac Anesthesia(UFTCA)

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

Intervention Type: PROCEDURE

conventional general anesthesia (CGA)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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%
• Ejection fraction (EF) ≥ 40%
• No contraindications to nerve blocks

Exclusion Criteria

• Patient's refusal to participate
• Severe communication disorders
• Severe disorders of coagulation with spontaneous bleeding tendency
• Long-term application of opioid analgesics
• Pulmonary hypertension (mean pulmonary artery pressure ≥55 mmHg)
• People who need artificial ventilation
• Allergy to dexmedetomidine and ropivacaine
• Complex aortic root surgery such as root widening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: collaborator

Tianjin Chest Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei J Yan, QC

Role: STUDY_CHAIR

Zhejiang Provincial People's Hospital

Central Contacts

Mei J Yan, QC

Role: CONTACT

1514018695@qq.com

+863313957116714

Han W Wei, secretary

Role: CONTACT

wzero1017@163.com

+863317816112656

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Other Identifiers

099

Identifier Type: -

Identifier Source: org_study_id