Phase 4
N=69
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Neuromuscular Blockade · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03322657 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent — 8; 3 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Neostigmine (Drug); Glycopyrrolate (Drug); Sugammadex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent |
8; 3 | <0.001 sig |
| PRIMARY TOF Ratio at 90 Min |
1.07; 1.16 | 0.13 |
| SECONDARY The Time for Extubation After Administration of Reversal Agents |
8; 8 | 0.30 |
| SECONDARY Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s |
-0.04; 0.29 | 0.21 |
| SECONDARY Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s |
-0.02; 0.80 | 0.04 sig |
Summary
The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status 1-3;
- Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
- General anesthesia.
Exclusion Criteria
- Suspected difficult intubation;
- Neuromuscular disorder;
- Renal impairment creatinine ≥ 2 mg /dl;
- Hepatic dysfunction;
- History of malignant hyperthermia;
- Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
- Perioperative respiratory infections and/or pneumonia;
- Intubated or unresponsive;
- Pregnancy or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03322657). 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.