Avoiding Neuromuscular Blockers to Reduce Complications

NCT03962725 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2019P000260
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Failure; Respiratory Infection; Aspiration Pneumonia; Pneumonitis; Atelectasis; Bronchospasm

Keywords

Neuromuscular Blocker Avoidance; Post Operative Pulmonary Complications; General Anesthesia Maintenance; Inhaled Anesthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vasopressor Use Between Groups

  During the surgery

• Duration of Intraoperative Hypotension

  During the surgery

• Surgeon's Assessment of surgical field

  During the surgery

Other Outcomes (5)

• 30-Day Readmission Rates

  30 days

• Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness

  Day after surgery

• Cost of Anesthetic Medication

  During the surgery

Study Arms (2)

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.

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.

Drug: Anesthetic Adjuncts

Interventions

Neuromuscular Blocking Agents DRUG

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

Also known as: Rocuronium

Control Group (C)

Anesthetic Adjuncts DRUG

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

Also known as: opioids, propofol, dexmedetomidine or ketamine

No Relaxant Group (NR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Tract Infections; Pneumonia, Aspiration; Pneumonia; Pulmonary Atelectasis; Bronchial Spasm

Interventions

Neuromuscular Blocking Agents; Rocuronium; Analgesics, Opioid; Propofol; Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Infections; Lung Diseases; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Analgesics; Sensory System Agents; Central Nervous System Agents; Therapeutic Uses; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Maximilian S Schaefer, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesia

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 24, 2019
• Study Start: August 7, 2019
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)