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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

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Respiratory Infection Aspiration Pneumonia Pneumonitis Atelectasis Bronchospasm Drug: Neuromuscular Blocking Agents Drug: Anesthetic Adjuncts Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
Estimated Study Start Date : July 17, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
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.
Drug: Neuromuscular Blocking Agents
Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
Other Name: Rocuronium

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Vasopressor Use Between Groups [ Time Frame: During the surgery ]
    Vasopressor equivalent dose

  2. Duration of Intraoperative Hypotension [ Time Frame: During the surgery ]
    Mean arterial pressure <55mmHg

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Cost of Anesthetic Medication [ Time Frame: During the surgery ]
    Cost of anesthetics used during surgical procedures in the study.

  4. 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.

  5. Hospital Length of Stay [ Time Frame: Upto 30 days ]
    How much total time patients spent in the hospital after the operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03962725


Contacts
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Contact: Somnath Bose, MD (617) 754-2129 sbose2@bidmc.harvard.edu
Contact: Valerie Banner-Goodspeed, MPH (617) 667-3112 vgoodspe@bidmc.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Marcos Vidal Melo, MD    617-726-8980    VidalMelo.Marcos@mgh.harvard.edu   
Contact: Peter Santer, MD    617-667-3112    psanter@bidmc.harvard.edu   
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Somnath Bose, MD    617-754-2129    sbose2@bidmc.harvard.edu   
Contact: Valerie Banner-Goodspeed, MPH    617-667-3112    vgoodspe@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

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Responsible Party: Somnath Bose, MD, Instructor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03962725     History of Changes
Other Study ID Numbers: 2019-P-000260
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Somnath Bose, MD, Beth Israel Deaconess Medical Center:
Neuromuscular Blocker Avoidance
Post Operative Pulmonary Complications
General Anesthesia Maintenance
Inhaled Anesthetics

Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Respiratory Tract Infections
Pulmonary Atelectasis
Bronchial Spasm
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infection
Bronchial Diseases
Anesthetics
Propofol
Ketamine
Dexmedetomidine
Analgesics, Opioid
Rocuronium
Neuromuscular Blocking Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists