NCT01718860

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

October 29, 2012

Last Update Submit

May 1, 2017

Conditions

Residual Paralysis, Post-Anesthesia

Keywords

Cost AnalysisPostoperative ComplicationsLength of StayIntensive Care Units

Outcome Measures

Primary Outcomes (1)

  • Hospital costs

    Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks

Secondary Outcomes (1)

  • Hospital Length of Stay

    within 100 days after surgery

Other Outcomes (3)

  • Incidence of postoperative respiratory complications

    Within one month after surgery

  • Incidence of unplanned postoperative intensive care unit admission

    Within one week after surgery

  • Length of stay in the post-anesthesia care unit (PACU)

    Patients will be followed until PACU discharge, an expected 2 days to 2 weeks

Study Arms (2)

Postoperative Residual Paralysis

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

Procedure: Quantitative measurement of neuromuscular transmission

No Postoperative Residual Paralysis

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

Procedure: Quantitative measurement of neuromuscular transmission

Interventions

Quantitative measurement of neuromuscular transmissionPROCEDURE

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

No Postoperative Residual ParalysisPostoperative Residual Paralysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who arrived at the post-anesthesia care unit after receiving neuromuscular blocking agents as part of their surgical anaesthesia.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

  • 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: 20576632BACKGROUND

  • 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.

    PMID: 20980910BACKGROUND

  • 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.

    PMID: 18635478BACKGROUND

  • 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.

    PMID: 9366929BACKGROUND

  • 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.

    PMID: 23077290BACKGROUND

  • 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.

    PMID: 25225821BACKGROUND

  • 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.

    PMID: 31094777DERIVED

MeSH Terms

Conditions

Delayed Emergence from AnesthesiaPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Eikermann, MD, PhD

    Partners

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

April 1, 2011

Primary Completion

February 1, 2014

Study Completion

December 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)