Provider Variability in the Use of Neuromuscular Blocking Drugs and Reversal

NCT03585348 | Completed

• 2 other identifiers: 2017P0006412017P002631
• Study Type: observational
• Target: 265,537
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Neuromuscular blocking agents ED95 equivalent dose or reversal agents dose (neostigmine and/or sugammadex)

  Neuromuscular blocking agent ED95 equivalent dose defined as the median effective dose required to achieve a 95% reduction in maximal twitch response from baseline.

  During surgery, maximum of 24 hours

Other Outcomes (2)

• Respiratory Complications

  Up to 7 days after surgery

• Direct costs of care

  During hospital stay, on average 4 days, and no longer than 1 year

Study Arms (1)

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

Interventions

Neuromuscular blocking agents OTHER

Neuromuscular blocking agent ED95 equivalent dose by provider

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

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

  BACKGROUND

• 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.

  PMID: 29121289 BACKGROUND

• 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.

  PMID: 20442260 BACKGROUND

• Xara D, Silva A, Mendonca 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.

  PMID: 23965209 BACKGROUND

• 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.

  PMID: 20576632 BACKGROUND

• Lepouse 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. doi: 10.1093/bja/ael094. Epub 2006 May 2.

  PMID: 16670111 BACKGROUND

• 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.

  PMID: 25251919 BACKGROUND

• 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(8):CD012763. doi: 10.1002/14651858.CD012763.

  PMID: 28806470 BACKGROUND

• 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.

  PMID: 25935840 BACKGROUND

• 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.

  PMID: 23757472 BACKGROUND

• 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.

  PMID: 25919486 BACKGROUND

• 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.

  PMID: 29974459 BACKGROUND

• 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.

  PMID: 28763357 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neuromuscular Blocking Agents

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Philipp Fassbender, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: June 29, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

US (2)