The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
Condition: Valvular Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; ERAS group; Conventional control group; ERAS group; Conventional control group; Conventional control group; Conventional control group; Conventional control group; Conventional control group; Conventional control group
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Intravenous infusion of flucloxacillin sodium 1g an hour before operation; No routine bowel preparation;
Normal eating 1 days before the operation;
No drinking 2h and solid food 6h before the operation;
Drink 10% glucose 250ml 3h before operation ;
Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);; Emphasize the preoperative psychological preparation for patients.; Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；; No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;; Solu-Medrol®:5mg/kg intravenous infusion during the surgery;; Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
Goal-directed fluid management.; Infusion of Human Albumin Grifol®20% 50ml;
Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®));
Shorten the Cardio-pulmonary Bypass line；
Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）); Monitor urine volume closely, over 0.5ml/kg·h.; Protective ventilation strategy：Low tidal volume about 6~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver; Bilateral thoracic paravertebral block before induction of anesthesia;
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.; Drink water after 6h, 200ml once, 2~3 times / day，
early ambulation，mobilization within 48 h,
Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd；
Intravenous the lansoprazole 30mg q12h.; Routine preoperative psychological preparation for patients.; 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).; Routine bowel preparation;
Liquid food eating 2 days before the operation;; Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;; Induction use Sufentanil 0.5~1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2~0.6mg/kg,Midazolam0.05~0.1mg/kg ;
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;; Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h; Intravenous infusion of dexamethasone 20mg during the surgery; Intravenous infusion of flucloxacillin sodium 1g before the operation
Other intervention name(s): "yifen®","Flucloxacillin"; Recombinant Human Erythropoietin; "Methylprednisolone"，"Solu-Medrol® "; Cardio-pulmonary Bypass measures, during the surgery; Kidney protection measure during the surgery; Lung protection measure during the surgery（Dräger Primus）; Anesthesia drugs during the surgery; Gastrointestinal protection measures after the surgery; Analgesia drugs after the surgery; scopolamine and morphine; Routine use of anesthesia medicine during the surgery; Routine use of anesthesia medicine after the surgery; Dexamethasone; "yifen®","Flucloxacillin"
Intervention MeSH terms: Floxacillin; Dexamethasone; Methylprednisolone; Methylprednisolone Hemisuccinate; Scopolamine; Morphine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Enhanced Recovery after Surgery