Avoiding Neuromuscular Blockers to Reduce Complications

Browse trials for

• Respiratory Insufficiency 1,369
• Respiratory Tract Infections 751
• Pneumonia, Aspiration 72
• Pneumonia 1,564
• Pulmonary Atelectasis 377
• Bronchial Spasm 44

Keywords

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

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 3 is below the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.

Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.

Study arms

• 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

• 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

Interventions

• DrugNeuromuscular Blocking Agents

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

  Also known as: Rocuronium

• DrugAnesthetic Adjuncts

  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

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

   Time frame: 28 Days

Secondary outcomes

1. Vasopressor Use Between Groups

   Vasopressor equivalent dose

   Time frame: During the surgery

2. Duration of Intraoperative Hypotension

   Minutes of mean arterial pressure \<55mmHg

   Time frame: During the surgery

3. 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

Other outcomes

1. 30-Day Readmission Rates

   Number of patients readmitted to the hospital within 30 days of discharge from hospital following index procedure.

   Time frame: 30 days

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

   Time is takes for patients to be ready for discharge from PACU post operatively.

   Time frame: Day after surgery

3. Cost of Anesthetic Medication

   Cost of anesthetics used during surgical procedures in the study.

   Time frame: During the surgery

4. 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.

   Time frame: 24 hours

5. Hospital Length of Stay

   How much total time patients spent in the hospital after the operation.

   Time frame: Upto 30 days

Baseline characteristics

Study documents

• Protocol and statistical analysis plan ↗ · Jan 10, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No