Clinical Trials Directory

Trials / Completed

CompletedNCT02479581

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
226 (actual)
Sponsor
Xiangya Hospital of Central South University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREERAS groupIntravenous infusion of flucloxacillin sodium 1g an hour before operation
PROCEDUREERAS group1. 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);
PROCEDUREERAS groupEmphasize the preoperative psychological preparation for patients.
PROCEDUREERAS groupReceived subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；
PROCEDUREERAS groupNo scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
PROCEDUREERAS groupSolu-Medrol®:5mg/kg intravenous infusion during the surgery;
PROCEDUREERAS group1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction; 2. Goal-directed fluid management.
PROCEDUREERAS group1. 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®）)
PROCEDUREERAS groupMonitor urine volume closely, over 0.5ml/kg·h.
PROCEDUREERAS groupProtective ventilation strategy：Low tidal volume about 6\~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
PROCEDUREERAS group1. 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.
PROCEDUREERAS group1. 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.
PROCEDUREConventional control groupRoutine preoperative psychological preparation for patients.
PROCEDUREERAS groupAfter 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).
PROCEDUREConventional control group1. Routine bowel preparation; 2. Liquid food eating 2 days before the operation;
PROCEDUREConventional control groupIntramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
PROCEDUREConventional control group1. 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;
PROCEDUREConventional control groupUse self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
PROCEDUREConventional control groupIntravenous infusion of dexamethasone 20mg during the surgery
PROCEDUREConventional control groupIntravenous infusion of flucloxacillin sodium 1g before the operation

Timeline

Start date
2015-07-01
Primary completion
2016-11-01
Completion
2017-05-01
First posted
2015-06-24
Last updated
2017-06-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02479581. Inclusion in this directory is not an endorsement.