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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) Applied on Cardiac Surgery With Cardiopulmonary Bypass: a Single Center, Randomized, Controlled Clinical Study

Conditions

Valvular Heart Disease

Being tested

ERAS group, Conventional control group

Keywords

Enhanced Recovery after Surgery

Medical subject headings

Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ERAS groupProcedure or surgery

  Also called "yifen®","Flucloxacillin"

  Intravenous infusion of flucloxacillin sodium 1g an hour before operation

• ERAS groupProcedure or surgery

  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 or surgery

  Emphasize the preoperative psychological preparation for patients.

• ERAS groupProcedure or surgery

  Also called Recombinant Human Erythropoietin

  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 or surgery

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

• ERAS groupProcedure or surgery

  Also called "Methylprednisolone"，"Solu-Medrol® "

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

• ERAS groupProcedure or surgery

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

• ERAS groupProcedure or surgery

  Also called Cardio-pulmonary Bypass measures, during the surgery

  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 or surgery

  Also called Kidney protection measure during the surgery

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

• ERAS groupProcedure or surgery

  Also called Lung protection measure during the surgery（Dräger Primus）

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

• ERAS groupProcedure or surgery

  Also called Anesthesia drugs during the surgery

  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 or surgery

  Also called Gastrointestinal protection measures after the surgery

  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 or surgery

  Routine preoperative psychological preparation for patients.

• ERAS groupProcedure or surgery

  Also called Analgesia drugs after the surgery

  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 or surgery

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

• Conventional control groupProcedure or surgery

  Also called scopolamine and morphine

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

• Conventional control groupProcedure or surgery

  Also called Routine use of anesthesia medicine during the surgery

  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 or surgery

  Also called Routine use of anesthesia medicine after the surgery

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

• Conventional control groupProcedure or surgery

  Also called Dexamethasone

  Intravenous infusion of dexamethasone 20mg during the surgery

• Conventional control groupProcedure or surgery

  Also called "yifen®","Flucloxacillin"

  Intravenous infusion of flucloxacillin sodium 1g before the operation

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The postoperative hospital time

   Measured: From pre-surgery to discharge, up to 4 weeks

2. Length of ICU stay

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

3. The time of readiness to discharge

   Measured: From pre-surgery to discharge, up to 4 weeks

4. The length of hospital stay

   Measured: From pre-surgery to discharge, up to 8 weeks

5. Hospitalization cost

   Measured: When the patient is discharged

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Jun 2015 (estimated)
2. Study startJul 2015
3. Primary completionNov 2016
4. Study completionMay 2017

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
• More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.