Effects of Postoperative Residual Paralysis on Hospital Costs

Residual Paralysis, Post-Anesthesia Clinical Trial

Official title:

Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01718860
• Other study ID #: 2016P002695
• Secondary ID: IISP#39443
• Status: Active, not recruiting
• Phase: N/A
• First received: October 29, 2012
• Last updated: May 1, 2017
• Start date: April 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2017
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Paralysis
• Residual Paralysis, Post-Anesthesia

Intervention

Procedure:
• Quantitative measurement of neuromuscular transmission
Quantitative measurement of neuromuscular transmission with train-of-four watches.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of postoperative respiratory complications		Within one month after surgery
Other	Incidence of unplanned postoperative intensive care unit admission	Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.	Within one week after surgery
Other	Length of stay in the post-anesthesia care unit (PACU)		Patients will be followed until PACU discharge, an expected 2 days to 2 weeks
Primary	Hospital costs		Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks
Secondary	Hospital Length of Stay		within 100 days after surgery