Clinical trial NCT03962725: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Respiratory Failure
Respiratory Infection
Aspiration Pneumonia
Pneumonitis
Atelectasis
Bronchospasm
Keywords: Neuromuscular Blocker Avoidance
Post Operative Pulmonary Complications
General Anesthesia Maintenance
Inhaled Anesthetics
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure.
timeFrame: 28 Days
Secondary outcomes:
measure: Vasopressor Use Between Groups
timeFrame: During the surgery
measure: Duration of Intraoperative Hypotension
timeFrame: During the surgery
measure: Surgeon's Assessment of surgical field
timeFrame: During the surgery
Other outcomes:
measure: 30-Day Readmission Rates
timeFrame: 30 days
measure: Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness
timeFrame: Day after surgery
measure: Cost of Anesthetic Medication
timeFrame: During the surgery
measure: Rate of Unplanned ICU Admission or Return to Operating Room
timeFrame: 24 hours
measure: Hospital Length of Stay
timeFrame: Upto 30 days
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Maximilian S Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References: