Surgery
Conditions
Keywords
neuromuscular blockade, sugammadex, SUG, neostigmine, NEO/GLYCO, 17-207
Brief summary
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.
Interventions
DRUGNeostigmine+glycopyrrolate
At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
DRUGSugammadex
At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients age 18 years of age or greater who are capable of giving consent * Undergoing surgical procedures of expected length 6 \</= hours requiring NMB
Exclusion criteria
* Pregnancy * History of documented anaphylaxis or contraindication to any of the study medications * Active coronary disease with a positive cardiac stress test * History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 \< 50% of predicted * Serum Creatinine \>/= 2.0 mg/dL * Severe hepatic dysfunction accompanied by coagulopathy * Definition: * Known liver Disease AND * INR \> 1.5 (except for patients on anticoagulants) AND * Platelet count \<100,00/ul without other obvious cause * Chronic sustained release opioid for \> 2 weeks duration pre op (in the 30 days prior to surgery) * Use of toremifene * Significant cognitive impairment or documented psychologic impairment * Myasthenia gravis or other neuromuscular disease * Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation. * American Society of Anesthesiologists (ASA) Status \> 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Participants' Recovery Time Post-Surgery | 1 day | Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Blockade Reversed With Neostigmine/Gly Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate | 100 |
| Neuromuscular Blockade Reversed With Sugammadex Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex | 101 |
| Total | 201 |
Baseline characteristics
| Characteristic | Total | Neuromuscular Blockade Reversed With Neostigmine/Gly | Neuromuscular Blockade Reversed With Sugammadex |
|---|---|---|---|
| Age, Continuous | 55 years | 55 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 188 Participants | 94 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 9 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) White | 159 Participants | 86 Participants | 73 Participants |
| Region of Enrollment United States | 201 Participants | 100 Participants | 101 Participants |
| Sex: Female, Male Female | 131 Participants | 62 Participants | 69 Participants |
| Sex: Female, Male Male | 70 Participants | 38 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 100 | 16 / 101 |
| other Total, other adverse events | 0 / 100 | 0 / 101 |
| serious Total, serious adverse events | 2 / 100 | 2 / 101 |
Outcome results
Primary
Measure Participants' Recovery Time Post-Surgery
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Neuromuscular Blockade Reversed With Neostigmine/Gly | Measure Participants' Recovery Time Post-Surgery | 3.59 hours |
| Neuromuscular Blockade Reversed With Sugammadex | Measure Participants' Recovery Time Post-Surgery | 3.62 hours |