Clinical trial NCT01718860: Effects of Postoperative Residual Paralysis on Hospital Costs
Official title: Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Residual Paralysis, Post-Anesthesia
Keywords: Cost Analysis
Postoperative Complications
Length of Stay
Intensive Care Units
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-10-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who arrived at the post-anesthesia care unit after receiving neuromuscular blocking agents as part of their surgical anaesthesia.

Brief summary: This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care.

Secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive care unit (ICU) admission rate, as well as length of stay in the PACU.


Eligibility criteria: Inclusion Criteria:

* Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia.
* Each subject must be at least 18 years of age
* Train-of-four monitoring in the post-anesthesia care unit

Exclusion Criteria:

* The subject is scheduled to be transferred to an intensive care unit after surgery.
* Children and pregnant women

Primary outcomes:
measure: Hospital costs
timeFrame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: within 100 days after surgery
Other outcomes:
measure: Incidence of postoperative respiratory complications
timeFrame: Within one month after surgery
measure: Incidence of unplanned postoperative intensive care unit admission
timeFrame: Within one week after surgery
measure: Length of stay in the post-anesthesia care unit (PACU)
timeFrame: Patients will be followed until PACU discharge, an expected 2 days to 2 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Partners
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
citation: Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
citation: Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
citation: Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
citation: Grabitz SD, Rajaratnam N, Chhagani K, Thevathasan T, Teja BJ, Deng H, Eikermann M, Kelly BJ. The Effects of Postoperative Residual Neuromuscular Blockade on Hospital Costs and Intensive Care Unit Admission: A Population-Based Cohort Study. Anesth Analg. 2019 Jun;128(6):1129-1136. doi: 10.1213/ANE.0000000000004028.