Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal
Study Details
Study Description
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 | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | 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
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Outcome Measures
Primary Outcome Measures
- Neuromuscular blocking agents ED95 equivalent dose or reversal agents dose (neostigmine and/or sugammadex) [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
- Respiratory Complications [Up to 7 days after surgery]
Respiratory complications defined as pneumonia, respiratory failure, pulmonary edema, or reintubation.
- Direct costs of care [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Non-cardiac surgical procedure
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Endotracheally intubated for surgery and extubated at the end of the case
Exclusion Criteria:
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American Society of Anesthesiologists (ASA) Classification Status of 5 or 6
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Other surgery within a month prior to the procedure considered
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Missing covariates
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
- Massachusetts General Hospital
Investigators
- Principal Investigator: Philipp Fassbender, MD, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
- Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
- Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8:CD012763. doi: 10.1002/14651858.CD012763. Review.
- Intercontinental Marketing Services (IMS) Health, Multinational Integrated Data Analysis System (MIDAS), September 2010
- Kotake Y, Ochiai R, Suzuki T, Ogawa S, Takagi S, Ozaki M, Nakatsuka I, Takeda J. Reversal with sugammadex in the absence of monitoring did not preclude residual neuromuscular block. Anesth Analg. 2013 Aug;117(2):345-51. doi: 10.1213/ANE.0b013e3182999672. Epub 2013 Jun 11.
- Ladha KS, Bateman BT, Houle TT, De Jong MAC, Vidal Melo MF, Huybrechts KF, Kurth T, Eikermann M. Variability in the Use of Protective Mechanical Ventilation During General Anesthesia. Anesth Analg. 2018 Feb;126(2):503-512. doi: 10.1213/ANE.0000000000002343.
- Lepousé C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. Epub 2006 May 2.
- Lien CA, Kopman AF. Current recommendations for monitoring depth of neuromuscular blockade. Curr Opin Anaesthesiol. 2014 Dec;27(6):616-22. doi: 10.1097/ACO.0000000000000132. Review.
- McLean DJ, Diaz-Gil D, Farhan HN, Ladha KS, Kurth T, Eikermann M. Dose-dependent Association between Intermediate-acting Neuromuscular-blocking Agents and Postoperative Respiratory Complications. Anesthesiology. 2015 Jun;122(6):1201-13. doi: 10.1097/ALN.0000000000000674.
- Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. Review.
- Rudolph MI, Chitilian HV, Ng PY, Timm FP, Agarwala AV, Doney AB, Ramachandran SK, Houle TT, Eikermann M. Implementation of a new strategy to improve the peri-operative management of neuromuscular blockade and its effects on postoperative pulmonary complications. Anaesthesia. 2018 Sep;73(9):1067-1078. doi: 10.1111/anae.14326. Epub 2018 Jul 4.
- Thevathasan T, Shih SL, Safavi KC, Berger DL, Burns SM, Grabitz SD, Glidden RS, Zafonte RD, Eikermann M, Schneider JC. Association between intraoperative non-depolarising neuromuscular blocking agent dose and 30-day readmission after abdominal surgery. Br J Anaesth. 2017 Oct 1;119(4):595-605. doi: 10.1093/bja/aex240.
- Xará D, Silva A, Mendonça J, Abelha F. Inadequate emergence after anesthesia: emergence delirium and hypoactive emergence in the Postanesthesia Care Unit. J Clin Anesth. 2013 Sep;25(6):439-46. doi: 10.1016/j.jclinane.2013.02.011. Epub 2013 Aug 17.
- 2017P000641
- 2017P002631