Study of Current Standard of Care in the U.S.: Incidence of postoperative events and associated costs among non-cardiac surgery patients exposed to neuromuscular blocking agents in the Cleveland Clinic (2005-2013)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  This study aims at evaluating the unmet needs among patients using any neuromuscular blocking agents to support any drugs that could be used in this setting.
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M03A) MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS

  MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS

  (M03AC03) vecuronium

  vecuronium

  (M03AC09) rocuronium bromide

  rocuronium bromide

  (N07AA) Anticholinesterases

  Anticholinesterases

Population studied

• Short description of the study population:
  Patients receiving any type of neuromuscular blocking agents and registered within the Cleveland Clinic Perioperative Health Documentation System between April 2005 and December 2013 will be included.; ; Patients will be excluded from the study if they have any of the following:; 1. participating in Bridion clinical trials; 2. incomplete data on age, gender, exposure to sedatives, opioids, antibiotics, AChE inhibitors, ASA status and type of surgery
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  This study will provide information on the current burden of unmet needs, healthcare resource utilization and costs for patients exposed to NMBAs.
• Outcomes:
  To identify patients with pre-specified post-operative events occurring in the Post Anesthesia Care Unit (PACU) and estimate the incidence among NMBA patients.To describe and compare the demographic, past medical history and operative characteristics of patients who experienced postoperative events and patients who did not experience any postoperative event. To describe the difference in healthcare resource utilization and costs between patients who have a postoperative complication and those who do not.To describe the difference in healthcare resource utilization and costs between patients with varying number of major and minor complications, as well as varying number of organ systems affected by major complications.
• Data analysis plan:
  1. The incidence of specific pre-defined postoperative events occurring in the PACU will be assessed among patients receiving any NMBA as well as for subpopulations of patients.2. The difference in healthcare resource utilization between patients with any complication and those without a complication will be described after matching on predictive score of postoperative complications.