Clinical trial NCT01933841: The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
Official title: The Impact of Quantitative Neuromuscular Monitoring in the PACU on Residual Blockade and Postoperative Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Weakness
Keywords: Post operative residual curarization
Neuromuscular blocking drugs
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who receive an intraoperative neuromuscular blockade

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.

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

Primary outcomes:
measure: Decrease in incidence of postoperative residual curarization
timeFrame: 10 minute after arrival to PACU
Secondary outcomes:
measure: Decrease in the incidence of hemoglobin desaturation
timeFrame: PACU stay (Typically 1-2 hours post-operatively)
measure: Decrease in need for reintubation
timeFrame: 24 hours after PACU entry
measure: Decrease in length of stay in the PACU
timeFrame: PACU stay (Typically 1-2 hours post-operatively)
measure: Decrease in incidence of perioperative pneumonia
timeFrame: 28 days post-operatively
measure: Decrease in time to readiness for discharge
timeFrame: Hospital stay (Expected average of 3 days)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Edward R Sherwood, M.D.
role: PRINCIPAL_INVESTIGATOR
References: