Phase 4
N=62
Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Incomplete Reversal of Neuromuscular Block
Bottom Line
View on ClinicalTrials.gov: NCT02909439 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes — -700; -862 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes |
-700; -862 | — |
| PRIMARY Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes |
-500; -1150 | — |
| PRIMARY Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes |
-400; -850 | — |
| SECONDARY Grip Strength, Change From Baseline and Recovery Profile 30 Min |
24.15; 21.38 | — |
| SECONDARY Grip Strength, Change From Baseline and Recovery Profile 60 Min |
12.68; 17.69 | — |
| SECONDARY Grip Strength, Change From Baseline and Recovery Profile 120 Min |
7.84; 11.85 | — |
| SECONDARY Time to Extubation |
8; 7 | — |
| SECONDARY Train of Four Ratio > 90% During PACU Admission |
25; 25 | — |
| SECONDARY Quality of Recovery 15 Survey |
117; 105 | — |
| SECONDARY Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9) |
109; 112 | — |
Summary
This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.
Eligibility Criteria
Inclusion Criteria
- Participant must be willing and able to provide written informed consent for the study
- Participant must be greater than or equal to 18 years of age
- Participant must be ASA (American Society of Anesthesiologists) class I, II or III
- Planned use of neuromuscular blocking drugs
- Planned use of endotracheal intubation
- Planned for extubation to occur in the OR
Exclusion Criteria
- ASA (American Society of Anesthesiologists) Class IV
- Age < 18 years old
- Inability to give oral or written consent
- Known or suspected neuromuscular disorder impairing neuromuscular function
- True allergy to muscle relaxants
- A (family) history of malignant hyperthermia
- A contraindication for neostigmine or sugammadex administration
- Serum creatinine level of greater than 2.0 mg/dL
- Surgery where the patient's arm is not available for neuromuscular monitoring
- A plan to extubate under deep anesthesia
- Pregnant
Data sourced from ClinicalTrials.gov (NCT02909439). 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.