The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

Xiangya Hospital of Central South University226 enrolled

Overview

This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half will under the conventional postoperative care.

Enhanced recovery after surgery (ERAS) or fast-track surgery is a perioperative and postoperative care concept initiated in the early 1990s aiming to reduce the length of hospital stays following elective abdominal surgery. The success of ERAS depends highly on multidisciplinary teamwork and patient compliance. This study intends to compare the Enhanced Recovery After Surgery (ERAS) concept applied to patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass under traditional perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an effective perioperative management during cardiopulmonary bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

226

Conditions

Valvular Heart Disease

Interventions

ERAS groupPROCEDURE

Intravenous infusion of flucloxacillin sodium 1g an hour before operation

ERAS groupPROCEDURE

1. No routine bowel preparation; 2. Normal eating 1 days before the operation; 3. No drinking 2h and solid food 6h before the operation; 4. Drink 10% glucose 250ml 3h before operation ; 5. Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);

ERAS groupPROCEDURE

Emphasize the preoperative psychological preparation for patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute) * The in - hospital was treated with extracorporeal circulation operation and general anesthesia. * Had a good cognition, and signed the informed consent. * Aged between 18 and 70. * The age, clinical examination and other generally situation of the two groups of patients had no statistical significance. Exclusion Criteria: * Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease. * Patients with severe mental disorders cannot cooperate with the treatment. * Emergency operation * Have taboo of Echocardiography and pulmonary catheterization by echocardiography. * Patients have been fitted with a pacemaker. * Allergic to erythropoietin. * Suspected or had alcohol, drug abuse history. * Spinal deformity or paravertebral lesions.

Locations (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

The postoperative hospital time

Time frame: From pre-surgery to discharge, up to 4 weeks

Length of ICU stay

Time frame: From entering the ICU to roll out, up to 4 weeks

The time of readiness to discharge

Time frame: From pre-surgery to discharge, up to 4 weeks

The length of hospital stay

Time frame: From pre-surgery to discharge, up to 8 weeks

Hospitalization cost

Time frame: When the patient is discharged

Secondary Outcomes

Perioperative major adverse events

Time frame: From pre-surgery to discharge, up to 4 weeks

Vasoactive drugs Support Hours

Time frame: From the start of drugs to stop them, up to 4 weeks

Postoperative tracheal tube time

Time frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks

Duration of mechanical ventilation after surgery

Time frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks

Time to first bowel movement

Time frame: From the end of surgery to first exhaust, up to 2 weeks

Postoperative time to first exhaust

Time frame: From the end of surgery to first exhaust, up to 2 weeks

Data from ClinicalTrials.gov

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Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；

ERAS groupPROCEDURE

No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;

ERAS groupPROCEDURE

Solu-Medrol®:5mg/kg intravenous infusion during the surgery;

ERAS groupPROCEDURE

1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction; 2. Goal-directed fluid management.

ERAS groupPROCEDURE

1. Infusion of Human Albumin Grifol®20% 50ml; 2. Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®)); 3. Shorten the Cardio-pulmonary Bypass line； 4. Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)

ERAS groupPROCEDURE

Monitor urine volume closely, over 0.5ml/kg·h.

ERAS groupPROCEDURE

Protective ventilation strategy：Low tidal volume about 6\~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver

ERAS groupPROCEDURE

1. Bilateral thoracic paravertebral block before induction of anesthesia; 2. Fast channel anesthesia: * Induction use Sufentanil 0.5\~1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2\~0.6mg/kg; ②. Maintain use Remifentanil Hydrochloride for Injection 0.1\~0.4ug/kg·min, Propofol Injection 2\~6mg/kg·h, Sevoflurane 0.5\~1.5（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg·h,Vecuronium 0.06\~0.12mg/kg·h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.

ERAS groupPROCEDURE

1. Drink water after 6h, 200ml once, 2\~3 times / day， 2. early ambulation，mobilization within 48 h, 3. Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd； 4. Intravenous the lansoprazole 30mg q12h.

Conventional control groupPROCEDURE

Routine preoperative psychological preparation for patients.

ERAS groupPROCEDURE

After operation use Ropivacaine 100mg infiltrating intercostal wound and self-controlled intravenous analgesia pump is applicable(Sufentanil 0.05ug/kg·h combine with Ketamine 40ug/kg·h).

Conventional control groupPROCEDURE

1. Routine bowel preparation; 2. Liquid food eating 2 days before the operation;

Conventional control groupPROCEDURE

Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;

Conventional control groupPROCEDURE

1. Induction use Sufentanil 0.5\~1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2\~0.6mg/kg,Midazolam0.05\~0.1mg/kg ; 2. Maintain use Sufentanil 1\~2ug/kg·h, Propofol 4\~12mg/kg·h, Sevoflurane 1\~3(minimal alveolar concentration)， Vecuronium 0.06\~0.12mg/kg·h;

Conventional control groupPROCEDURE

Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h

Conventional control groupPROCEDURE

Intravenous infusion of dexamethasone 20mg during the surgery

Conventional control groupPROCEDURE

Intravenous infusion of flucloxacillin sodium 1g before the operation

Hemoglobin