Avoiding Neuromuscular Blockers to Reduce Complications

Phase 4TerminatedNCT03962725

Beth Israel Deaconess Medical Center3 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Respiratory Failure Respiratory Infection Aspiration Pneumonia Pneumonitis Atelectasis Bronchospasm

Interventions

Neuromuscular Blocking AgentsDRUG

Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.

Anesthetic AdjunctsDRUG

Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 28 Days

Secondary Outcomes

Vasopressor Use Between Groups

Vasopressor equivalent dose

Time frame: During the surgery

Duration of Intraoperative Hypotension

Mean arterial pressure \<55mmHg

Time frame: 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.

Time frame: During the surgery

Data from ClinicalTrials.gov

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