Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Days 1-30 Adult surgery patients whose operations occurred during Days 1-30 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.
  • Device: TOF-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.
    Other names:
    • Acceleromyographic monitoring
  • Procedure: Notify 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.
Days 31-60 Adult surgery patients whose operations occurred during Days 31-60 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.
  • Device: TOF-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.
    Other names:
    • Acceleromyographic monitoring
  • Procedure: Notify 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.
Days 61-90 Adult surgery patients whose operations occurred during Days 61-90 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.
  • Device: TOF-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.
    Other names:
    • Acceleromyographic monitoring
  • Procedure: Notify 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.
Days 91-120 Adult surgery patients whose operations occurred during Days 91-120 after monitoring is introduced in the PACU. Patients will have their TOF ratio measured and recorded using a TOF-Watch SX. The nurse will monitor the patient and notify the provider of the patient's TOF-ratio if appropriate.
  • Device: TOF-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.
    Other names:
    • Acceleromyographic monitoring
  • Procedure: Notify 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.

More Details

Status
Completed
Sponsor
Vanderbilt University Medical Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.