Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/16/2018 |
| Start Date: | May 21, 2018 |
| End Date: | November 20, 2018 |
| Contact: | Stephan R Thilen, MD, MS |
| Email: | sthilen@uw.edu |
| Phone: | 206-744-4371 |
Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.
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.
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.
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%.
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%.
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.
Exclusion Criteria: Allergy to neuromuscular blocking drugs, patients with neuromuscular
disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English
speaking.
We found this trial at
1
site
1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-3300
Phone: 206-618-2402
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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