Phase 4
Completed N=189
Best Management of Muscle Relaxation- Objective Monitoring
Residual Paralysis, Post Anesthesia
Source: ClinicalTrials.gov NCT03958201 ↗
Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation — 0 Participants
◆ Published Evidence
Established
27citations · ~14 / year
Management of Muscle Relaxation With Rocuronium and Reversal With Neostigmine or Sugammadex Guided by Quantitative Neuromuscular Monitoring.
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.
Linked Publications
-
Management of Muscle Relaxation With Rocuronium and Reversal With Neostigmine or Sugammadex Guided by Quantitative Neuromuscular Monitoring.
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 |
— | — |
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) and the linked publication. 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. Informational only — not medical advice.