Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal
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| ClinicalTrials.gov Identifier: NCT03585348 |
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Recruitment Status :
Completed
First Posted : July 13, 2018
Last Update Posted : August 25, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Neuromuscular Blockade Residual Curarisation, Postoperative Surgery Under General Anaesthesia | Other: Neuromuscular blocking agents |
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.
| Study Type : | Observational |
| Actual Enrollment : | 265537 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 |
| Actual Primary Completion Date : | March 31, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Neuromuscular blocking agents
Neuromuscular blocking agent ED95 equivalent dose by provider |
- 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.
- Respiratory Complications [ Time Frame: Up to 7 days after surgery ]Respiratory complications defined as pneumonia, respiratory failure, pulmonary edema, or reintubation.
- 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 |
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
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
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Philipp Fassbender, MD | Beth Israel Deaconess Medical Center |
| Responsible Party: | Philipp Fassbender, Assistant Professor of Anesthesia, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT03585348 |
| Other Study ID Numbers: |
2017P000641 2017P002631 ( Other Identifier: Massachusetts General Hospital ) |
| First Posted: | July 13, 2018 Key Record Dates |
| Last Update Posted: | August 25, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neuromuscular Blockade Agents Provider Variability Quality Improvement Perioperative Care Neuromuscular Blockade Reversal |
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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 |