Avoiding Neuromuscular Blockers to Reduce Complications
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|ClinicalTrials.gov Identifier: NCT03962725|
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : May 24, 2019
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Respiratory Infection Aspiration Pneumonia Pneumonitis Atelectasis Bronchospasm||Drug: Neuromuscular Blocking Agents Drug: Anesthetic Adjuncts||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial|
|Actual Study Start Date :||August 7, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
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 Name: 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 Name: opioids, propofol, dexmedetomidine or ketamine
- Number of participants who either had postoperative pulmonary complications or died in hospital within 28 days of index procedure. [ Time Frame: 28 Days ]Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality
- Vasopressor Use Between Groups [ Time Frame: During the surgery ]Vasopressor equivalent dose
- Duration of Intraoperative Hypotension [ Time Frame: During the surgery ]Mean arterial pressure <55mmHg
- Surgeon's Assessment of surgical field [ Time Frame: 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.
- 30-Day Readmission Rates [ Time Frame: 30 days ]How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.
- Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness [ Time Frame: Day after surgery ]Time is takes for patients to be ready for discharge from PACU post operatively.
- Cost of Anesthetic Medication [ Time Frame: During the surgery ]Cost of anesthetics used during surgical procedures in the study.
- Rate of Unplanned ICU Admission or Return to Operating Room [ Time Frame: 24 hours ]How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation.
- Hospital Length of Stay [ Time Frame: Upto 30 days ]How much total time patients spent in the hospital after the operation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962725
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Maximilian S Schaefer, MD||Beth Israel Deaconess Medical Center|