Avoiding Neuromuscular Blockers to Reduce Complications

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Suspended

CT.gov ID

NCT03962725

Collaborator

(none)

100

Enrollment

Locations

Arms

40.8

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Respiratory Infection Aspiration Pneumonia Pneumonitis Atelectasis Bronchospasm	Drug: Neuromuscular Blocking Agents Drug: Anesthetic Adjuncts	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Aug 7, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: opioids, propofol, dexmedetomidine or ketamine

Arm

Intervention/Treatment

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 Names:

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 Names:

opioids, propofol, dexmedetomidine or ketamine

Outcome Measures

Primary Outcome Measures

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

Vasopressor Use Between Groups [During the surgery]
Vasopressor equivalent dose
Duration of Intraoperative Hypotension [During the surgery]
Mean arterial pressure <55mmHg
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.

Other Outcome Measures

30-Day Readmission Rates [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 [Day after surgery]
Time is takes for patients to be ready for discharge from PACU post operatively.
Cost of Anesthetic Medication [During the surgery]
Cost of anesthetics used during surgical procedures in the study.
Rate of Unplanned ICU Admission or Return to Operating Room [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 [Upto 30 days]
How much total time patients spent in the hospital after the operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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