Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
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|ClinicalTrials.gov Identifier: NCT03543826|
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness||Other: Protocol for rocuronium neuromuscular block||Not Applicable|
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%.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||November 20, 2018|
|Estimated Study Completion Date :||November 20, 2018|
Patients will have perioperative nuromuscular block managed by protocol. The protocol includes specified appropriate rocuronium dosing and reversal with either neostigmine or sugammadex depending on depth of block as assessed subjectively at adductor pollicis with standard train-of-four stimulation of the ulnar nerve.
Other: Protocol for rocuronium neuromuscular block
The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
- 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. ]Train-of-four ratio <0.9 as measured by electromyography
- 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. ]Train-of-four ratio <0.7 as measured by electromyography
- Incidence of postoperative residual neuromuscular blockade at time of tracheal extubation. [ Time Frame: Within two minutes of time of extubation. ]Train-of-four ratio <0.9 as measured by electromyography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543826
|Contact: Stephan R Thilen, MD, MSemail@example.com|
|Contact: Sanjay M Bhananker, MDfirstname.lastname@example.org|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Stephan Thilen 206-618-2402 email@example.com|
|Principal Investigator:||Stephan R Thilen, MD, MS||University of Washington|