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

NCT ID: NCT01933841

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Muscle Weakness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

TOF-Watch SX

Intervention Type DEVICE

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.

Notify the provider

Intervention Type PROCEDURE

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.

TOF-Watch SX

Intervention Type DEVICE

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.

Notify the provider

Intervention Type PROCEDURE

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.

TOF-Watch SX

Intervention Type DEVICE

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.

Notify the provider

Intervention Type PROCEDURE

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.

TOF-Watch SX

Intervention Type DEVICE

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.

Notify the provider

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Acceleromyographic monitoring

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Edward Sherwood

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward R Sherwood, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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131282

Identifier Type: -

Identifier Source: org_study_id

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