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

Ketamine

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.

Intervention / Treatment

  • 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).
  • Conventional control group (PROCEDURE)
    Intravenous infusion of flucloxacillin sodium 1g before the operation

Condition or Disease

  • Valvular Heart Disease

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 226 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2015 ACTUAL
    Primary Completion: Nov 01, 2016 ACTUAL
    Completion Date: May 01, 2017 ACTUAL
    Study First Posted: Jun 24, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 31, 2017

    Sponsors / Collaborators

    Lead Sponsor: Xiangya Hospital of Central South University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Hunan, China
    Changsha, Hunan, China

    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.

    Participant Groups

    • Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program

    • Perioperative management follows the conventional program

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • 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
    Secondary Outcomes
    • 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
    • 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

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    • 1day before and 1-5days after operation

    Other Outcomes
    • Questions to the participants' health Six month

    More Details

    NCT Number: NCT02479581
    Acronym: ERAS
    Other IDs: liman20150516
    Study URL: https://clinicaltrials.gov/study/NCT02479581
    Last updated: Sep 29, 2023