Safety of Intraoperative Use of Muscle Relaxants and Their Reversal Agent Neostigmine

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 6, 2013
Last verified: May 2013
  Purpose

The investigators evaluate the assumption that postoperative residual curarization is associated with impaired gas exchange upon post anesthesia care unit arrival and longer hospital length of stay. Additionally, the investigators also evaluate the assumption the use of neostigmine reversal of residual neuromuscular block is associated with an increased incidence of postoperative pulmonary complications and intensive care unit admission.


Condition
Postoperative Residual Curarization
Impaired Gas Exchange
Atelectasis
Hospital Length of Stay
Postoperative ICU Admission

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consequences on Respiratory Morbidity and Health-care Utilization of Partial Paralysis Upon Admission to the Postanesthesia Care.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Impaired gas exchange [ Time Frame: Within 10 min. upon PACU arrival ] [ Designated as safety issue: Yes ]
    Gas exchange is assessed by a ratio of pulse oxymetry oxygen saturation relative to fraction of inspired oxygen. Oxygen saturation at PACU admission is defined as the first oxygen saturation value written by an independent nurse in patients' clinical PACU note.


Secondary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: within 100 days after surgery ] [ Designated as safety issue: No ]
    Hospital length of stay is defined as the length from the day of the surgery to hospital discharge.


Other Outcome Measures:
  • Incidence of postoperative atelectasis [ Time Frame: Within one month after surgery ] [ Designated as safety issue: Yes ]
    Diagnosis of atelectasis will be retrieved from the hospital billing data.

  • Incidence of unplanned postoperative intensive care unit admission [ Time Frame: Within one week after surgery ] [ Designated as safety issue: Yes ]
    Incidence of unplanned postoperative intensive care unit admission due to respiratory failure, pulmonary edema and arrhythmia.


Estimated Enrollment: 3000
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
non-depolarizing muscle relaxants
The investigators enroll patients arriving in the postanesthesia care unit after receiving non-depolarizing neuromuscular blocking agents as part of their surgical anesthesia.

Detailed Description:

The investigators' laboratory has recently identified the intraoperative use of intermediate-acting non-depolarizing neuromuscular blocking agents and neostigmine reversal of neuromuscular blockade as independent risk factors for severe postoperative respiratory complications. Additionally, the investigators found that postoperative residual curarization (PORC), defined as a train-of-four ratio less than 0.90 upon postanesthesia care unit (PACU) arrival, is associated with an increased PACU length of stay.

To examine the mechanisms contributing to the association of neuromuscular transmission failure with postoperative respiratory complications, the investigators aim to evaluate in a performance improvement driven initiative to better understand the association between the use of neuromuscular blocking agents and reversal agents with postoperative respiratory complications (see British Medical Journal 2012 Oct 15;345:e6329) if patients presenting with PORC develop subsequently 1) an increased incidence of postoperative impaired gas exchange upon PACU admission and result in 2) an increased hospital length of stay. In addition the investigators evaluated the effects of neostigmine on signs and symptoms of postoperative respiratory dysfunction and an incidence of unplanned postoperative intensive care unit admission.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients given non-depolarizing neuromuscular blocking agents as part of general anesthesia

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

Exclusion Criteria:

  • The subject is scheduled to be transferred to an intensive care unit after surgery.
  Contacts and Locations
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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, Associate professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01718860     History of Changes
Other Study ID Numbers: 2011P000454, IISP#39443
Study First Received: October 29, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
PORC
neostigmine

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Neuromuscular Nondepolarizing Agents
Neostigmine
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents

ClinicalTrials.gov processed this record on August 28, 2014