Back to resultsAvoiding Neuromuscular Blockers to Reduce Complications
Primary Purpose
Respiratory Failure, Respiratory Infection, Aspiration Pneumonia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Blocking Agents
Anesthetic Adjuncts
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Neuromuscular Blocker Avoidance, Post Operative Pulmonary Complications, General Anesthesia Maintenance, Inhaled Anesthetics
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group (C)
No Relaxant Group (NR)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure.
Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality
Secondary Outcome Measures
Vasopressor Use Between Groups
Vasopressor equivalent dose
Duration of Intraoperative Hypotension
Mean arterial pressure <55mmHg
Surgeon's Assessment of surgical field
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.
Full Information
NCT ID
NCT03962725
First Posted
May 21, 2019
Last Updated
January 31, 2023
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03962725
Brief Title
Avoiding Neuromuscular Blockers to Reduce Complications
Official Title
Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of enrollment.
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Respiratory Infection, Aspiration Pneumonia, Pneumonitis, Atelectasis, Bronchospasm
Keywords
Neuromuscular Blocker Avoidance, Post Operative Pulmonary Complications, General Anesthesia Maintenance, Inhaled Anesthetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (C)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Relaxant Group (NR)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Neuromuscular Blocking Agents
Other Intervention Name(s)
Rocuronium
Intervention Description
Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Anesthetic Adjuncts
Other Intervention Name(s)
opioids, propofol, dexmedetomidine or ketamine
Intervention Description
Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.
Primary Outcome Measure Information:
Title
Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure.
Description
Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Vasopressor Use Between Groups
Description
Vasopressor equivalent dose
Time Frame
During the surgery
Title
Duration of Intraoperative Hypotension
Description
Mean arterial pressure <55mmHg
Time Frame
During the surgery
Title
Surgeon's Assessment of surgical field
Description
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.
Time Frame
During the surgery
Other Pre-specified Outcome Measures:
Title
30-Day Readmission Rates
Description
How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.
Time Frame
30 days
Title
Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness
Description
Time is takes for patients to be ready for discharge from PACU post operatively.
Time Frame
Day after surgery
Title
Cost of Anesthetic Medication
Description
Cost of anesthetics used during surgical procedures in the study.
Time Frame
During the surgery
Title
Rate of Unplanned ICU Admission or Return to Operating Room
Description
How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation.
Time Frame
24 hours
Title
Hospital Length of Stay
Description
How much total time patients spent in the hospital after the operation.
Time Frame
Upto 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maximilian S Schaefer, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Avoiding Neuromuscular Blockers to Reduce Complications
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