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

Vanderbilt University Medical Center1 site in 1 country201 target enrollmentAugust 2016

Overview

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 Description

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.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

July 2017

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Vanderbilt University Medical Center

Responsible Party

Principal Investigator

Edward Sherwood

Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

•Surgical patients \> 18 years of age
•Received one or more NMBDs during surgery
•Surgery took place during the first 120 days following the introduction of TOF monitoring in the PACU

Exclusion Criteria

•Surgical patients \< 18 years of age
•Received no NMBDs during surgery
•Transfer from the OR to the PACU was delayed (by high PACU volume, for example)
•Had a procedure or has a preexisting condition that prevents accurate monitoring

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Decrease in need for reintubation(24 hours after PACU entry)
Decrease in incidence of perioperative pneumonia(28 days post-operatively)
Decrease in time to readiness for discharge(Hospital stay (Expected average of 3 days))
Decrease in length of stay in the PACU(PACU stay (Typically 1-2 hours post-operatively))
Decrease in the incidence of hemoglobin desaturation(PACU stay (Typically 1-2 hours post-operatively))