Effects of Postoperative Residual Paralysis on Hospital Costs

NCT ID: NCT01718860

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Residual Paralysis, Post-Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Postoperative Residual Paralysis

Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit

Quantitative measurement of neuromuscular transmission

Intervention Type PROCEDURE

Quantitative measurement of neuromuscular transmission with train-of-four watches.

No Postoperative Residual Paralysis

Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit

Quantitative measurement of neuromuscular transmission

Intervention Type PROCEDURE

Quantitative measurement of neuromuscular transmission with train-of-four watches.

Interventions

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Quantitative measurement of neuromuscular transmission

Quantitative measurement of neuromuscular transmission with train-of-four watches.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Eikermann

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Eikermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Partners

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20576632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20980910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18635478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9366929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23077290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25225821 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31094777 (View on PubMed)

Other Identifiers

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IISP#39443

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016P002695

Identifier Type: -

Identifier Source: org_study_id

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