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Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal

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ClinicalTrials.gov Identifier: NCT03585348
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Matthias Eikermann, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment
Neuromuscular Blockade Residual Curarisation, Postoperative Surgery Under General Anaesthesia Other: Neuromuscular blocking agents

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.


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Study Type : Observational
Estimated Enrollment : 250000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Importance of Understanding Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal Agents
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
Study cohort
The estimated cohort consists of 317.000 adult patients who are intubated for a non-cardiac surgery and extubated at the end of the case at Beth Israel Deaconess Medical Center (205.000) as well as Massachusetts General Hospital (112.000) and received treatment by anesthesia and surgical providers who have completed at least 50 anesthesias and surgeries at their respective institution, respectively.
Other: Neuromuscular blocking agents
Neuromuscular blocking agent ED95 equivalent dose by provider




Primary Outcome Measures :
  1. Neuromuscular blocking agents ED95 equivalent dose or reversal agents dose (neostigmine and/or sugammadex) [ Time Frame: During surgery, maximum of 24 hours ]
    Neuromuscular blocking agent ED95 equivalent dose defined as the median effective dose required to achieve a 95% reduction in maximal twitch response from baseline.


Other Outcome Measures:
  1. Respiratory Complications [ Time Frame: Up to 7 days after surgery ]
    Respiratory complications defined as pneumonia, respiratory failure, pulmonary edema, or reintubation.

  2. Direct costs of care [ Time Frame: During hospital stay, on average 4 days, and no longer than 1 year ]
    Direct costs of care defined as costs incurred from admission to discharge day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing non-cardiac surgical procedure that are intubated for surgery and extubated at the end of the case.
Criteria

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

Information from the National Library of Medicine

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): NCT03585348


Contacts
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Contact: Matthias Eikermann, MD PhD (617) 632-7034 meikerma@bidmc.harvard.edu
Contact: Maria Patrocinio, MD msilvadi@bidmc.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Timothy Houle, PhD       THOULE1@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthias Eikermann, MD PhD    617-632-7034    meikerma@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
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Principal Investigator: Matthias Eikermann, MD PhD Beth Israel Deaconess Medical Center

Publications:
Intercontinental Marketing Services (IMS) Health, Multinational Integrated Data Analysis System (MIDAS), September 2010

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Responsible Party: Matthias Eikermann, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03585348     History of Changes
Other Study ID Numbers: 2017P000641
2017P002631 ( Other Identifier: Massachusetts General Hospital )
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Eikermann, Beth Israel Deaconess Medical Center:
Neuromuscular Blockade Agents
Provider Variability
Quality Improvement
Perioperative Care
Neuromuscular Blockade Reversal

Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs