Respiratory FailurePhase 4NCT03962725
Avoiding Neuromuscular Blockers to Reduce Complications
A Phase 4 study testing Neuromuscular Blocking Agents and Anesthetic Adjuncts in people with Respiratory Failure and Respiratory Infection, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Infection, Aspiration Pneumonia
- What is being tested?
- Neuromuscular Blocking Agents and Anesthetic Adjuncts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2019to 19 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
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.
Read the 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.
- Conditions
- Respiratory Failure, Respiratory Infection, Aspiration Pneumonia, Pneumonitis, Atelectasis, Bronchospasm
- Being tested
- Neuromuscular Blocking Agents, Anesthetic Adjuncts
- Keywords
- Neuromuscular Blocker Avoidance, Post Operative Pulmonary Complications, General Anesthesia Maintenance, Inhaled Anesthetics
- Medical subject headings
- Respiratory Insufficiency, Respiratory Tract Infections, Pneumonia, Aspiration, Pneumonia, Pulmonary Atelectasis, Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Blocking AgentsDrug
Also called Rocuronium
Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
Anesthetic AdjunctsDrug
Also called opioids, propofol, dexmedetomidine or ketamine
Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (C) | Active comparator | 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. Receives: Drug: Neuromuscular Blocking Agents |
| No Relaxant Group (NR) | Experimental | 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. Receives: Drug: Anesthetic Adjuncts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 Days
Secondary outcomes (3)
Vasopressor Use Between Groups
Vasopressor equivalent dose
Measured: During the surgery
Duration of Intraoperative Hypotension
Minutes of mean arterial pressure <55mmHg
Measured: During the surgery
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.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start7 Aug 2019
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Why it stopped: Study terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian S Schaefer, Beth Israel Deaconess Medical Center
- Investigators
- Maximilian S Schaefer, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962725
- Sponsor's protocol ID
- 2019P000260
- Status last verified
- May 2026
- First submitted
- 21 May 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03962725
- Acronym / sponsor ID
- 2019P000260
- Conditions
- Respiratory Failure, Respiratory Infection, Aspiration Pneumonia, Pneumonitis, Atelectasis, Bronchospasm
- Keywords
- Neuromuscular Blocker Avoidance, Post Operative Pulmonary Complications, General Anesthesia Maintenance, Inhaled Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (C) | Active comparator | Drug: Neuromuscular Blocking AgentsEndotracheal 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. |
| No Relaxant Group (NR) | Experimental | Drug: Anesthetic AdjunctsEndotracheal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Blocking AgentsAlso: RocuroniumUse of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia. | Drug | Control Group (C) |
| Anesthetic AdjunctsAlso: opioids, propofol, dexmedetomidine or ketamineUse of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia. | Drug | No Relaxant Group (NR) |
Primary outcome
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
3 secondary outcomes
Vasopressor Use Between Groups
Time frame: During the surgery
Duration of Intraoperative Hypotension
Time frame: During the surgery
Surgeon's Assessment of Surgical Field
Time frame: During the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian S Schaefer, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neuromuscular Blocking Agents and Anesthetic Adjuncts in people with Respiratory Failure and Respiratory Infection, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Either Had Postoperative Pulmonary Complications or Died in Hospital Within 28 Days of Index Procedure. (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.