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Avoiding Neuromuscular Blockers to Reduce Complications

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ClinicalTrials.gov Identifier: NCT03962725
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Somnath Bose, MD, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date July 9, 2019
Estimated Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure. [ Time Frame: 28 Days ]
Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03962725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Vasopressor Use Between Groups [ Time Frame: During the surgery ]
    Vasopressor equivalent dose
  • Duration of Intraoperative Hypotension [ Time Frame: During the surgery ]
    Mean arterial pressure <55mmHg
  • Surgeon's Assessment of surgical field [ Time Frame: During the surgery ]
    Was the operative condition optimal for the surgeon graded qualitatively using a numerical rating scale of 1-4. A score of 1 indicates excellent operating conditions whereas 4 indicates conditions unacceptable to the surgeon.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 23, 2019)
  • 30-Day Readmission Rates [ Time Frame: 30 days ]
    How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.
  • Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness [ Time Frame: Day after surgery ]
    Time is takes for patients to be ready for discharge from PACU post operatively.
  • Cost of Anesthetic Medication [ Time Frame: During the surgery ]
    Cost of anesthetics used during surgical procedures in the study.
  • Rate of Unplanned ICU Admission or Return to Operating Room [ Time Frame: 24 hours ]
    How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation.
  • Hospital Length of Stay [ Time Frame: Upto 30 days ]
    How much total time patients spent in the hospital after the operation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Avoiding Neuromuscular Blockers to Reduce Complications
Official Title  ICMJE Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
Brief Summary The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.
Detailed Description Pragmatic prospective randomized controlled assessor-blinded effect-size finding trial involving approximately 100 patients total at two academic tertiary care hospitals: Beth Israel Deaconess Medical Center (BIDMC) and Massachusetts General Hospital (MGH). Patients will be randomized into one of two study groups: standard care group which uses Rocuronium (NMBA) as an adjunct for maintenance of general anesthesia and non-relaxant arm that avoids the use of NMBA and instead uses additional inhalational anesthetics, opioids, propofol, dexmedetomidine, or ketamine for maintenance of general anesthesia. Assessment of postoperative pulmonary complications and in-hospital mortality would be achieved by close review of the patient's medical records during the hospital stay, for a maximum of 28 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Failure
  • Respiratory Infection
  • Aspiration Pneumonia
  • Pneumonitis
  • Atelectasis
  • Bronchospasm
Intervention  ICMJE
  • Drug: Neuromuscular Blocking Agents
    Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
    Other Name: Rocuronium
  • Drug: Anesthetic Adjuncts
    Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.
    Other Name: opioids, propofol, dexmedetomidine or ketamine
Study Arms  ICMJE
  • Active Comparator: Control Group (C)
    Endotracheal intubation would be facilitated by either Rocuronium (0.6-1mg kg-1) or Succinylcholine (1-1.5mg kg-1) and further dosing of Rocuronium would be left at the discretion of the anesthesia team members. Choice and technique of induction and maintenance of anesthesia, use of vasopressors, perioperative antibiotics, analgesics/adjunct regional techniques, prophylaxis for postoperative nausea and vomiting, fluid and blood component therapy would be left at the discretion of the anesthesia team. Neuromuscular blockade would be reversed with either Sugammadex or Neostigmine (based on institutional availability) and trachea would be extubated once patient meets criteria per attending anesthesiologist.
    Intervention: Drug: Neuromuscular Blocking Agents
  • Experimental: No Relaxant Group (NR)
    Endotracheal intubation would be facilitated by Succinylcholine (1-1.5mg/kg) or Remifentanil (1-2mcg kg-1) if Succinylcholine use is contraindicated. No non-depolarizing NMBA would be administered to the patients randomized to the NR group. Choice and technique of induction and maintenance of anesthesia, use of vasopressors, perioperative antibiotics, analgesics/adjunct regional techniques, prophylaxis for postoperative nausea and vomiting, fluid and blood component therapy would be left at the discretion of the anesthesia team. Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine) either as boluses or infusion would be recommended in case of sustained high peak airway pressures (>35mm Hg), high intra-abdominal pressure, involuntary patient/diaphragmatic movement hindering surgical exposure and dissection. Choice and dose of adjunct/s to optimize operating conditions would be left to the discretion of the anesthesia team.
    Intervention: Drug: Anesthetic Adjuncts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age
  • Undergoing non-cardiac surgery under general anesthesia with an endotracheal tube
  • those at higher risk of developing postoperative pulmonary complications (internally validated risk prediction score of >=20)

Exclusion Criteria:

  • Emergency surgery
  • Ambulatory (outpatient) surgery
  • Scheduled for elective postoperative ventilation
  • Planned return to operating room within 7 days of index procedure
  • Exposure to general anesthesia within 7 days prior to planned procedure
  • Requirement mechanical ventilation at baseline (not including stable use of CPAP/BiPAP)
  • Pregnant patients: as detected by patient self-reporting or diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC and MGH
  • Allergy to either non-depolarizing muscle relaxants or sugammadex
  • Clinician refusal
  • Prisoner
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Somnath Bose, MD (617) 754-2129 sbose2@bidmc.harvard.edu
Contact: Valerie Banner-Goodspeed, MPH (617) 667-3112 vgoodspe@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962725
Other Study ID Numbers  ICMJE 2019-P-000260
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Somnath Bose, MD, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP