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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01933841
Enrollment
201
Registered
2013-09-02
Start date
2016-08-31
Completion date
2017-07-31
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness

Keywords

Post operative residual curarization, Neuromuscular blocking drugs

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.

Interventions

DEVICETOF-Watch SX

As part of standard care, patients who undergo intraoperative neuromuscular blockade will have their TOF ratio measured and recorded during their first 10 minutes in the PACU by perioperative nursing staff.

PROCEDURENotify the provider

Based on the TOF reading, the patient's PACU nurse will page the provider who administered the block and/or a designated Reversal Support team member. The page will identify the patient and notify the provider of the suboptimal TOF ratio.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in incidence of postoperative residual curarization10 minute after arrival to PACUThis 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

MeasureTime frameDescription
Decrease in the incidence of hemoglobin desaturationPACU 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 reintubation24 hours after PACU entryThis 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 PACUPACU 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 pneumonia28 days post-operativelyThis 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 dischargeHospital 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026