Neuromuscular Blockade
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)
Detailed description
Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.
Interventions
DRUGsugammadex
DRUGNeostigmine
DRUGGlycopyrrolate
Sponsors
Merck Sharp & Dohme LLC
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
Intervention model description
Prospective Randomized Double Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for open ventral hernia repair or open colectomy * ASA class I-III * 18 years and older * Subjects with a body mass index (BMI) of \<45kg/m2 and weight less than 150kg * Subjects who have given written informed consent
Exclusion criteria
* Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker * Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis) * Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance \< 30 mL.min-1 * Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction * Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia; * Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients * Subjects who have a contraindication to, Rocuronium or Sugammadex * Female subjects who are pregnant * Morbidly obese subjects with a BMI \> 45 kg/m2 or weight more than 150 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. | through start of next surgery, average of 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications | through discharge from hospital, average of 72 hours |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neostigmine + Glycopyrrolate Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine
Glycopyrrolate | 25 |
| Sugammadex Sugammadex 4mg/kg
sugammadex | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Neostigmine + Glycopyrrolate | Total | Sugammadex |
|---|---|---|---|
| Age, Continuous | 44.3 Years STANDARD_DEVIATION 5.2 | 45.2 Years STANDARD_DEVIATION 5.7 | 45.6 Years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 40 Participants | 19 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 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 | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 40 Participants | 22 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
Time frame: through start of next surgery, average of 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neostigmine + Glycopyrrolate | Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. | 49.7 Minutes | Standard Deviation 16.18 |
| Sugammadex | Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. | 49.45 Minutes | Standard Deviation 16.67 |
Secondary
Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
Time frame: through discharge from hospital, average of 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neostigmine + Glycopyrrolate | Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications | 8 Participants |
| Sugammadex | Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications | 10 Participants |