Avoiding Neuromuscular Blockers to Reduce Complications

Respiratory Failure Clinical Trial

Official title:

Eliminating Use of Non Depolarizing Neuromuscular Blocking Agents to Reduce Postoperative Pulmonary Complications: A Multi-center, Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03962725
• Other study ID #: 2019P000260
• Status: Terminated
• Phase: Phase 4
• Start date: August 7, 2019
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Atelectasis
• Bronchial Spasm
• Bronchospasm
• Pneumonia
• Pneumonia, Aspiration
• Pneumonitis
• Pulmonary Atelectasis
• Respiratory Failure
• Respiratory Infection
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-Day Readmission Rates	How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.	30 days
Other	Time to Post-Anesthesia Care Unit (PACU) Discharge Readiness	Time is takes for patients to be ready for discharge from PACU post operatively.	Day after surgery
Other	Cost of Anesthetic Medication	Cost of anesthetics used during surgical procedures in the study.	During the surgery
Other	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.	24 hours
Other	Hospital Length of Stay	How much total time patients spent in the hospital after the operation.	Upto 30 days
Primary	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	28 Days
Secondary	Vasopressor Use Between Groups	Vasopressor equivalent dose	During the surgery
Secondary	Duration of Intraoperative Hypotension	Mean arterial pressure <55mmHg	During the surgery
Secondary	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.	During the surgery