NCT03962725

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Neuromuscular Blocking Agents	Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
DRUG	Anesthetic Adjuncts	Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.

Timeline

• Start date: 2019-08-07
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2019-05-24
• Last updated: 2023-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study