Phase 4
N=189
Best Management of Muscle Relaxation- Objective Monitoring
Residual Paralysis, Post Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03958201 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation |
— | — |
| SECONDARY Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation |
— | — |
Summary
The purpose of this study is to demonstrate that the investigators can reduce residual paralysis to a very low incidence, and that the investigators can do this while preserving a role for the older and less expensive reversal agent neostigmine. The investigators consider this an evidence-based approach because previous reports clearly indicate that neostigmine is effective for reversal of the most shallow neuromuscular blocks, a level of block now referred to as minimal block. The Investigators also know from previous data that a substantial proportion of patients have minimal block. Sugammadex will be used when the block to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio is <40%.
The investigators hypothesize that this protocol will be associated with an incidence of residual paralysis of less than 3%. The investigators plan is to study 200 patients.
Eligibility Criteria
Inclusion Criteria
- Are 18 years or older
- Undergoing surgery expected to last less than 6 hours at HMC or UWMC
- Have ASA physical status I-III
- Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or intraoperative neuromuscular block (NMB)
Exclusion Criteria
- Allergy to NMBDs, neostigmine, or sugammadex
- Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
- Pregnant or lactating women
- Non English speaking
- Unable to provide informed consent
- Severe renal failure with eGFR less than 20 ml/min
Data sourced from ClinicalTrials.gov (NCT03958201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.