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

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.

Conditions

• Valvular Heart Disease

Interventions

PROCEDURE

ERAS group

Intravenous infusion of flucloxacillin sodium 1g an hour before operation

PROCEDURE

ERAS group

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);

PROCEDURE

ERAS group

Emphasize the preoperative psychological preparation for patients.

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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®）)

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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

PROCEDURE

ERAS group

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.

PROCEDURE

ERAS group

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.

PROCEDURE

Conventional control group

Routine preoperative psychological preparation for patients.

PROCEDURE

ERAS group

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).

PROCEDURE

Conventional control group

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

PROCEDURE

Conventional control group

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

PROCEDURE

Conventional control group

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;

PROCEDURE

Conventional control group

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

PROCEDURE

Conventional control group

Intravenous infusion of dexamethasone 20mg during the surgery

PROCEDURE

Conventional control group

Intravenous infusion of flucloxacillin sodium 1g before the operation

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• e wang, phD · Xiangya Hospital of Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2016-11-30

Completion

2017-05-31

Countries

• China

Study Locations