Avoiding Neuromuscular Blockers to Reduce Complications

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.

Study Overview

• Status: Suspended
• Conditions: Respiratory Failure; Aspiration Pneumonia; Atelectasis; Respiratory Infection; Bronchospasm; Pneumonitis
• Intervention / Treatment: Drug: Neuromuscular Blocking Agents; Drug: Anesthetic Adjuncts

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group (C); 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.	Drug: Neuromuscular Blocking Agents; Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.; Other Names: Rocuronium
Experimental: No Relaxant Group (NR); 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.	Drug: Anesthetic Adjuncts; Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.; Other Names: opioids, propofol, dexmedetomidine or ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasopressor Use Between Groups	Vasopressor equivalent dose	During the surgery
Duration of Intraoperative Hypotension	Mean arterial pressure <55mmHg	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.	During the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-Day Readmission Rates	How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.	30 days
Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness	Time is takes for patients to be ready for discharge from PACU post operatively.	Day after surgery
Cost of Anesthetic Medication	Cost of anesthetics used during surgical procedures in the study.	During the surgery
Rate of Unplanned ICU Admission or Return to Operating Room	How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation.	24 hours
Hospital Length of Stay	How much total time patients spent in the hospital after the operation.	Upto 30 days

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Maximilian S Schaefer, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Neuromuscular Blocker Avoidance; Post Operative Pulmonary Complications; General Anesthesia Maintenance; Inhaled Anesthetics
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Bronchial Diseases; Pulmonary Atelectasis; Respiratory Insufficiency; Pneumonia; Pneumonia, Aspiration; Respiratory Tract Infections; Bronchial Spasm; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Ketamine; Anesthetics; Propofol; Dexmedetomidine; Rocuronium; Neuromuscular Blocking Agents
• Other Study ID Numbers: 2019P000260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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