Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 10 for:    "Heart Disease" | "Ropivacaine"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479581
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief 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.

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Procedure: ERAS group Procedure: Conventional control group Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ERAS group
Perioperative management follows the Enhanced Recovery after Surgery(ERAS) program
Procedure: ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
Other Name: "yifen®","Flucloxacillin"

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;
Other Name: Recombinant Human Erythropoietin

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;
Other Name: "Methylprednisolone","Solu-Medrol® "

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®))
Other Name: Cardio-pulmonary Bypass measures, during the surgery

Procedure: ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
Other Name: Kidney protection measure during the surgery

Procedure: ERAS group
Protective ventilation strategy:Low tidal volume about 6~8ml/kg and positive end expiratory pressure(PEEP) combined with lung recruitment maneuver
Other Name: Lung protection measure during the surgery(Dräger Primus)

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.
Other Name: Anesthesia drugs during the surgery

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.
Other Name: Gastrointestinal protection measures after the surgery

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).
Other Name: Analgesia drugs after the surgery

Experimental: Conventional control group
Perioperative management follows the conventional program
Procedure: ERAS group
Protective ventilation strategy:Low tidal volume about 6~8ml/kg and positive end expiratory pressure(PEEP) combined with lung recruitment maneuver
Other Name: Lung protection measure during the surgery(Dräger Primus)

Procedure: Conventional control group
Routine preoperative psychological preparation for patients.

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;
Other Name: scopolamine and morphine

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;
Other Name: Routine use of anesthesia medicine during the surgery

Procedure: Conventional control group
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
Other Name: Routine use of anesthesia medicine after the surgery

Procedure: Conventional control group
Intravenous infusion of dexamethasone 20mg during the surgery
Other Name: Dexamethasone

Procedure: Conventional control group
Intravenous infusion of flucloxacillin sodium 1g before the operation
Other Name: "yifen®","Flucloxacillin"




Primary Outcome Measures :
  1. The postoperative hospital time [ Time Frame: From pre-surgery to discharge, up to 4 weeks ]
  2. Length of ICU stay [ Time Frame: From entering the ICU to roll out, up to 4 weeks ]
  3. The time of readiness to discharge [ Time Frame: From pre-surgery to discharge, up to 4 weeks ]
  4. The length of hospital stay [ Time Frame: From pre-surgery to discharge, up to 8 weeks ]
  5. Hospitalization cost [ Time Frame: When the patient is discharged ]

Secondary Outcome Measures :
  1. Perioperative major adverse events [ Time Frame: From pre-surgery to discharge, up to 4 weeks ]
  2. Vasoactive drugs Support Hours [ Time Frame: From the start of drugs to stop them, up to 4 weeks ]
  3. Postoperative tracheal tube time [ Time Frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks ]
  4. Duration of mechanical ventilation after surgery [ Time Frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks ]
  5. Time to first bowel movement [ Time Frame: From the end of surgery to first exhaust, up to 2 weeks ]
  6. Postoperative time to first exhaust [ Time Frame: From the end of surgery to first exhaust, up to 2 weeks ]
  7. Hemoglobin [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  8. C-reactive protein [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  9. Procalcitonin [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  10. N-terminal B-type natriuretic peptide(NT-proBNP) [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  11. Serum Creatinine [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  12. Troponin I [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation

  13. Erythrocyte Sedimentation Rate [ Time Frame: baseline and 5 days after operation ]
    1day before and 1-5days after operation


Other Outcome Measures:
  1. Questions to the participants' health [ Time Frame: Six month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
  • 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:

  • Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479581


Locations
Layout table for location information
China, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410078
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
Layout table for investigator information
Study Director: e wang, phD Xiangya Hospital of Central South University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02479581     History of Changes
Other Study ID Numbers: liman20150516
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: February 2017
Keywords provided by Xiangya Hospital of Central South University:
Enhanced Recovery after Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Floxacillin
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Scopolamine
Morphine
Anesthetics
Epoetin Alfa
Butylscopolammonium Bromide
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Neuroprotective Agents