The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
NCT ID: NCT02479581
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2015-07-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
NCT03956420
Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project
NCT06786819
Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery
NCT02042547
Cardiac Rehabilitation in Coronary Artery Bypass Graft Surgery
NCT07006441
On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist
NCT02731794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ERAS group
Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program
ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
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);
ERAS group
Emphasize the preoperative psychological preparation for patients.
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；
ERAS group
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
ERAS group
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
ERAS group
1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
2. Goal-directed fluid management.
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®）)
ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
ERAS group
Protective ventilation strategy：Low tidal volume about 6\~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
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.
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.
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).
Conventional control group
Perioperative management follows the conventional program
ERAS group
Protective ventilation strategy：Low tidal volume about 6\~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
Conventional control group
Routine preoperative psychological preparation for patients.
Conventional control group
1. Routine bowel preparation;
2. Liquid food eating 2 days before the operation;
Conventional control group
Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
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;
Conventional control group
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
Conventional control group
Intravenous infusion of dexamethasone 20mg during the surgery
Conventional control group
Intravenous infusion of flucloxacillin sodium 1g before the operation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
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);
ERAS group
Emphasize the preoperative psychological preparation for patients.
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；
ERAS group
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
ERAS group
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
ERAS group
1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
2. Goal-directed fluid management.
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®）)
ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
ERAS group
Protective ventilation strategy：Low tidal volume about 6\~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
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.
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.
Conventional control group
Routine preoperative psychological preparation for patients.
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).
Conventional control group
1. Routine bowel preparation;
2. Liquid food eating 2 days before the operation;
Conventional control group
Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
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;
Conventional control group
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
Conventional control group
Intravenous infusion of dexamethasone 20mg during the surgery
Conventional control group
Intravenous infusion of flucloxacillin sodium 1g before the operation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiangya Hospital of Central South University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
e wang, phD
Role: STUDY_DIRECTOR
Xiangya Hospital of Central South University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bakker N, Cakir H, Doodeman HJ, Houdijk AP. Eight years of experience with Enhanced Recovery After Surgery in patients with colon cancer: Impact of measures to improve adherence. Surgery. 2015 Jun;157(6):1130-6. doi: 10.1016/j.surg.2015.01.016. Epub 2015 Mar 16.
Hoffmann H, Kettelhack C. Fast-track surgery--conditions and challenges in postsurgical treatment: a review of elements of translational research in enhanced recovery after surgery. Eur Surg Res. 2012;49(1):24-34. doi: 10.1159/000339859. Epub 2012 Jul 11.
Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
Li M, Zhang J, Gan TJ, Qin G, Wang L, Zhu M, Zhang Z, Pan Y, Ye Z, Zhang F, Chen X, Lin G, Huang L, Luo W, Guo Q, Wang E. Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
liman20150516
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.