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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

October 29, 2012
May 6, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01718860 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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.
  • 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: Withing 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.
 
Safety of Intraoperative Use of Muscle Relaxants and Their Reversal Agent Neostigmine
Consequences on Respiratory Morbidity and Health-care Utilization of Partial Paralysis Upon Admission to the Postanesthesia Care.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Postoperative Residual Curarization
  • Impaired Gas Exchange
  • Atelectasis
  • Hospital Length of Stay
  • Postoperative ICU Admission
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01718860
2011P000454, IISP#39443
No
Matthias Eikermann, Massachusetts General Hospital
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Matthias Eikermann, MD, PhD Partners
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP