Avoiding Neuromuscular Blockers to Reduce Complications

Phase 4

Terminated

• Conditions: Aspiration Pneumonia; Pneumonitis; Respiratory Failure; Respiratory Infection; Atelectasis; Bronchospasm
• Interventions: Drug: Neuromuscular Blocking Agents; Drug: Anesthetic Adjuncts

• Registration Number: NCT03962725
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Study Start: 2019-08-07
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (C)	Neuromuscular Blocking Agents	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.
No Relaxant Group (NR)	Anesthetic Adjuncts	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure.	28 Days	Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality

Secondary Outcome Measures

Name	Time	Method
Surgeon's Assessment of surgical field	During the surgery	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.
Vasopressor Use Between Groups	During the surgery	Vasopressor equivalent dose
Duration of Intraoperative Hypotension	During the surgery	Mean arterial pressure \<55mmHg

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States