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Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal

Importance of Understanding Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal Agents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03585348
Enrollment
265537
Registered
2018-07-13
Start date
2018-06-29
Completion date
2021-03-31
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade, Residual Curarisation, Postoperative, Surgery Under General Anaesthesia

Keywords

Neuromuscular Blockade Agents, Provider Variability, Quality Improvement, Perioperative Care, Neuromuscular Blockade Reversal

Brief summary

The use of neuromuscular blocking agents during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Understanding the clinical behavior of providers is essential in devising and assessing quality improvement projects since it is primarily individuals who determine the utilization of neuromuscular blocking drugs and reversal agents, not institutions. Therefore, the primary objective of this study is to determine the variability between individual anesthesia providers (attending physician, resident, nurse anesthetists) in the use of neuromuscular blocking drugs and reversal agents, using advanced statistical methods to adjust for differences in patient and procedure case mix. The investigators hypothesize that variance between individual anesthesia providers in the use of neuromuscular blocking drugs and reversal agents differs depending on provider type.

Detailed description

More than 400 million people receive neuromuscular blocking agents (NMBA) annually, either in the operating theatre to optimize surgical conditions, or in the intensive care unit to facilitate mechanical ventilation in those with patient-ventilator asynchrony. NMBA have been associated with increased morbidity secondary to postoperative residual neuromuscular blockade. The incidence of residual blockade is about 20-60% of patients and depends on compound and dose of NMBA reversal agent used. Despite disagreements over guidelines and thresholds to define the optimal strategy to optimize surgical conditions, there is growing evidence that very high doses of NMBA and neostigmine put the patients at risk of respiratory complications and hospital readmission. The investigators have recently shown that dedicated quality improvement initiatives substantially improve the utilization of non-depolarizing muscle relaxants and their reversal agents. This is a retrospective, observational, multi-centric cohort study based on on-file hospital data from two institutions, Massachusetts General Hospital and Beth Israel Deaconess Medical Center, Boston, Massachusetts. The investigators will compare the utilization of NMBA cross different groups of anesthesia providers (anesthesiologists, anesthesia residents, CRNAs) who provided anesthesia care in at least 100 cases in their institution. The investigators will control our provider-specific findings for patient-, procedure-, and hospital-specific differences in NMBA utilization. Primary objective is to determine the variability between individual anesthesia providers in the use of neuromuscular blocking drugs and reversal agents (neostigmine at Massachusetts General Hospital/MGH and neostigmine or sugammadex at Beth Israel Deaconess Medical Center/BIDMC) across provider-types (attending physician, resident, nurse anesthetists (CRNA)), experience level (number of cases done in an institution), and hospitals (MGH, BIDMC). Potential mechanisms of the provider variability will then be examined, such as providers´age, gender, race, profession, employment status and time of the procedure (surgery conducted during daytime versus nighttime). Additionally, the investigators will examine if the provider variance in the use of NMBA, neostigmine, and sugammadex (based on mean dose across providers and individual mean dose given for standardized surgical procedures) is associated with respiratory complications and direct costs of care.

Interventions

OTHERNeuromuscular blocking agents

Neuromuscular blocking agent ED95 equivalent dose by provider

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 18 years of age or older * Non-cardiac surgical procedure * Endotracheally intubated for surgery and extubated at the end of the case

Exclusion criteria

* American Society of Anesthesiologists (ASA) Classification Status of 5 or 6 * Other surgery within a month prior to the procedure considered * Missing covariates

Design outcomes

Primary

MeasureTime frameDescription
Neuromuscular blocking agents ED95 equivalent dose or reversal agents dose (neostigmine and/or sugammadex)During surgery, maximum of 24 hoursNeuromuscular blocking agent ED95 equivalent dose defined as the median effective dose required to achieve a 95% reduction in maximal twitch response from baseline.

Other

MeasureTime frameDescription
Respiratory ComplicationsUp to 7 days after surgeryRespiratory complications defined as pneumonia, respiratory failure, pulmonary edema, or reintubation.
Direct costs of careDuring hospital stay, on average 4 days, and no longer than 1 yearDirect costs of care defined as costs incurred from admission to discharge day.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026