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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS group | Experimental | Perioperative management follows the Enhanced Recovery after Surgery(ERAS) program |
|
| Conventional control group | Experimental | Perioperative management follows the conventional program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS group | Procedure | Intravenous infusion of flucloxacillin sodium 1g an hour before operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The postoperative hospital time | From pre-surgery to discharge, up to 4 weeks | |
| Length of ICU stay | From entering the ICU to roll out, up to 4 weeks | |
| The time of readiness to discharge | From pre-surgery to discharge, up to 4 weeks | |
| The length of hospital stay | From pre-surgery to discharge, up to 8 weeks | |
| Hospitalization cost | When the patient is discharged |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative major adverse events | From pre-surgery to discharge, up to 4 weeks | |
| Vasoactive drugs Support Hours | From the start of drugs to stop them, up to 4 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Questions to the participants' health | Six month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| e wang, phD | Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410078 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25791027 | Result | 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. | |
| 22797672 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2017 | |
| Unrelease | Yes | |
| Release | Aug 31, 2017 |
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| ERAS group | Procedure |
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| ERAS group | Procedure | Emphasize the preoperative psychological preparation for patients. |
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| ERAS group | Procedure | Received subcutaneous recombinant human erythropoietin (rhEPO)150(international unit/kg) once very two days from 2 days after hospital admission to 5 days postoperatively; |
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| ERAS group | Procedure | No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs; |
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| ERAS group | Procedure | Solu-Medrol®:5mg/kg intravenous infusion during the surgery; |
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| ERAS group | Procedure |
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| ERAS group | Procedure |
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| ERAS group | Procedure | Monitor urine volume closely, over 0.5ml/kg·h. |
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| ERAS group | Procedure | Protective ventilation strategy:Low tidal volume about 6~8ml/kg and positive end expiratory pressure(PEEP) combined with lung recruitment maneuver |
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| ERAS group | Procedure |
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| ERAS group | Procedure |
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| Conventional control group | Procedure | Routine preoperative psychological preparation for patients. |
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| ERAS group | Procedure | 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). |
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| Conventional control group | Procedure |
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| Conventional control group | Procedure | Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery; |
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| Conventional control group | Procedure |
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| Conventional control group | Procedure | Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h |
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| Conventional control group | Procedure | Intravenous infusion of dexamethasone 20mg during the surgery |
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| Conventional control group | Procedure | Intravenous infusion of flucloxacillin sodium 1g before the operation |
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| Postoperative tracheal tube time |
| From the end of surgery to the removal of tracheal tube, up to 4 weeks |
| Duration of mechanical ventilation after surgery | From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks |
| Time to first bowel movement | From the end of surgery to first exhaust, up to 2 weeks |
| Postoperative time to first exhaust | From the end of surgery to first exhaust, up to 2 weeks |
| Hemoglobin | 1day before and 1-5days after operation | baseline and 5 days after operation |
| C-reactive protein | 1day before and 1-5days after operation | baseline and 5 days after operation |
| Procalcitonin | 1day before and 1-5days after operation | baseline and 5 days after operation |
| N-terminal B-type natriuretic peptide(NT-proBNP) | 1day before and 1-5days after operation | baseline and 5 days after operation |
| Serum Creatinine | 1day before and 1-5days after operation | baseline and 5 days after operation |
| Troponin I | 1day before and 1-5days after operation | baseline and 5 days after operation |
| Erythrocyte Sedimentation Rate | 1day before and 1-5days after operation | baseline and 5 days after operation |
| 14667752 | Result | 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. |
| 29514224 | Derived | 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. |
| Reset | Apr 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2017 | Yes | |||
| Aug 31, 2017 | Apr 12, 2018 |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| D012601 | Scopolamine |
| D009020 | Morphine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D013259 | Steroids, Fluorinated |
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