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Completed

NCT Number: NCT03543826

Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

This is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. The protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a train-of-four ration <0.9.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

This study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. The study is an extension of the recently published study by Thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). It demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (TOF) ratio <0.7 at time of tracheal extubation. It was also associated with a highly significant reduction in PRNB as defined for several secondary outcomes, including non-normalized (i.e. raw) TOF-ratio <0.9 at time of arrival to the post-anesthesia care unit (PACU).

The current study does not include a control group, only an intervention group. The investigators hypothesize that PRNB can be prevented by adhering to a protocol which incorporates several current recommendations by experts. Importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis TOF response. The investigators will study only abdominal surgery and orthopedic surgery patients. The primary outcome is incidence of PRNB, defined as TOF-ratio <0.9 on arrival to the PACU. The investigators plan to enroll 120 patients, and if no more than one patient has PRNB, the upper bound for the 95% confidence interval will be less than 5%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult 18 years old or older, Will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last <6 hours at Harborview or Univ of Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade.

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Exclusion criteria

Allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English speaking.

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Treatment and study plan

Protocol for rocuronium neuromuscular block

Combination Product

The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.

Primary outcomes

  1. Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.

    Time frame: Within five minutes of arrival to the post-anesthesia care unit.

    Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio <0.9 as measured by acceleromyography.

Secondary outcomes

  1. Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.

    Time frame: Within five minutes of arrival to the post-anesthesia care unit.

    Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio <0.7 as measured by acceleromyography.

  2. Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.

    Time frame: Within two minutes of time of extubation.

    Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio <0.9 as measured by acceleromyography.

  3. Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation

    Time frame: Within two minutes of time of extubation.

    Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio <0.7 as measured by acceleromyography.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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