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Effects of Postoperative Residual Paralysis on Hospital Costs

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01718860
First received: October 29, 2012
Last updated: May 1, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Residual Paralysis, Post-Anesthesia Procedure: Quantitative measurement of neuromuscular transmission

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate

Resource links provided by NLM:


Further study details as provided by Matthias Eikermann, Massachusetts General Hospital:

Primary Outcome Measures:
  • Hospital costs [ Time Frame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks ]

Secondary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: within 100 days after surgery ]

Other Outcome Measures:
  • Incidence of postoperative respiratory complications [ Time Frame: Within one month after surgery ]
  • Incidence of unplanned postoperative intensive care unit admission [ Time Frame: Within one week after surgery ]
    Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.

  • Length of stay in the post-anesthesia care unit (PACU) [ Time Frame: Patients will be followed until PACU discharge, an expected 2 days to 2 weeks ]

Estimated Enrollment: 3000
Study Start Date: April 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
Procedure: Quantitative measurement of neuromuscular transmission
Quantitative measurement of neuromuscular transmission with train-of-four watches.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718860

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD Partners
  More Information

Publications:

Responsible Party: Matthias Eikermann, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01718860     History of Changes
Other Study ID Numbers: 2016P002695
IISP#39443 ( Other Grant/Funding Number: MERCK & CO INC )
Study First Received: October 29, 2012
Last Updated: May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
Cost Analysis
Postoperative Complications
Length of Stay
Intensive Care Units

Additional relevant MeSH terms:
Paralysis
Delayed Emergence from Anesthesia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 17, 2017