Aspiration Pneumonia, Atelectasis, Bronchospasm, Pneumonitis, Respiratory Failure, Respiratory Infection
Conditions
Keywords
Neuromuscular Blocker Avoidance, Post Operative Pulmonary Complications, General Anesthesia Maintenance, Inhaled Anesthetics
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.
Interventions
DRUGNeuromuscular Blocking Agents
Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
DRUGAnesthetic Adjuncts
Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Either Had Postoperative Pulmonary Complications or Died in Hospital Within 28 Days of Index Procedure. | 28 Days | Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor Use Between Groups | During the surgery | Vasopressor equivalent dose |
| Duration of Intraoperative Hypotension | During the surgery | Minutes of mean arterial pressure \<55mmHg |
| Surgeon's Assessment of Surgical Field | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaximilian S Schaefer, MD
Beth Israel Deaconess Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
None listed