Effects of Postoperative Residual Paralysis on Hospital Costs

May 1, 2017 updated by: Matthias Eikermann, Massachusetts General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Length of Stay
Time Frame: within 100 days after surgery
within 100 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative respiratory complications
Time Frame: Within one month after surgery
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.
Within one week after surgery
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
Patients will be followed until PACU discharge, an expected 2 days to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Matthias Eikermann, MD, PhD, Partners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P002695
  • IISP#39443 (Other Grant/Funding Number: MERCK & CO INC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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