Clinical Trial: The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery

Brief Summary:

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. The Post Anesthesia Care Unit will be introducing monitoring as part of standard of care. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

Our study is designed to test the following hypotheses:

Hypothesis 1: The initiation of quantitative TOF monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at VUMC.

Hypothesis 2: The initiation of the routine TOF monitoring program will decrease the incidence of short- and long-term postoperative complications at VUMC.


Detailed Summary:

Neuromuscular blocking drugs (NMBDs) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. NMBD-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (PORC), is present in as many as 40% of all patients that receive neuromuscular blocking agents. Physiological data suggest that PORC impairs normal respiratory function, and compelling evidence suggests PORC impairs clinical recovery in the immediate postoperative period and prolongs PACU length of stay. However, despite the widespread use of NMBDs and the frequent occurrence of PORC, limitations in the literature prevent an understanding of their full impact on clinical outcomes. This study will collect data about patients who receive NMBDs and examine the impact of monitoring on incidences of PORC.

The incidence of PORC and postoperative complications after the introduction of monitoring in the PACU will be determined by measuring TOF ratios and tracking the postoperative outcomes in the surgical patients over time.


Sponsor: Vanderbilt University

Current Primary Outcome: Decrease in incidence of postoperative residual curarization [ Time Frame: 10 minute after arrival to PACU ]

This aim will test the hypothesis that initiation of quantitative Train-Of-Four monitoring as part of the standard PACU entry evaluation will change practitioner behavior in a manner that decreases the incidence of PORC in surgical patients at Vanderbilt University Medical Center. Quantitative TOF monitoring will be introduced as a standard component of the PACU entry evaluation for all patients that receive NMBDs as part of their care. It is expected that the proportion of patients with TOF < 0.9 will decrease over time after initiation of the routine monitoring system.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease in the incidence of hemoglobin desaturation [ Time Frame: PACU stay (Typically 1-2 hours post-operatively) ]
    This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
  • Decrease in need for reintubation [ Time Frame: 24 hours after PACU entry ]
    This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
  • Decrease in length of stay in the PACU [ Time Frame: PACU stay (Typically 1-2 hours post-operatively) ]
    This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease short-term postoperative complications.
  • Decrease in incidence of perioperative pneumonia [ Time Frame: 28 days post-operatively ]
    This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease long-term postoperative complications.
  • Decrease in time to readiness for discharge [ Time Frame: Hospital stay (Expected average of 3 days) ]
    This aim is part of a group of aims which will test the hypothesis that initiation of the routine TOF monitoring program will decrease long-term postoperative complications.


Original Secondary Outcome: Same as current

Information By: Vanderbilt University

Dates:
Date Received: August 23, 2013
Date Started: August 2013
Date Completion: September 2017
Last Updated: May 9, 2016
Last Verified: May 2016