General Surgery
Conditions
Keywords
Postoperative respiratory depression, Neuromuscular Agents
Brief summary
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.
Interventions
DRUGSugammadex
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
DRUGPlacebo
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Sponsors
Merck Sharp & Dohme LLC
University of Texas
Respiratory Motion, Inc.
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing surgery with general anesthesia * Patients weighing \> or = 80 pounds * Patients not intubated prior to surgery * Patients who are able to give informed consent
Exclusion criteria
* Patients unable to give informed consent. * Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron * Patients who are anticipated to remain intubated in recovery period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased Minute Ventilation (MV) | 15---30 minutes after Post-anesthesia care unit (PACU) arrival | The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. |
| Decreased Average Minute Ventilation (MV) | 15---30 minutes after Post-anesthesia care unit (PACU) arrival | The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Train of Four (TOF) Ratio | upon PACU discharge, approximately 8 hours | The number of subjects to have a normal TOF ratio (\>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex Subjects had Sugammadex administered after routine reversal of anesthesia was performed and subject was extubated.
Sugammadex: Sugammadex administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated. | 127 |
| Placebo Subjects had Placebo administered after routine reversal of anesthesia was performed and subject was extubated.
Placebo: Placebo was administered intravenously at 2 mg/kg after routine reversal of anesthesia was performed and subject was extubated. | 133 |
| Total | 260 |
Baseline characteristics
| Characteristic | Sugammadex | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.65 years STANDARD_DEVIATION 16.74 | 52.13 years STANDARD_DEVIATION 16.07 | 52.87 years STANDARD_DEVIATION 16.39 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 67 Participants | 128 Participants |
| Region of Enrollment United States | 127 participants | 133 participants | 260 participants |
| Sex: Female, Male Female | 45 Participants | 37 Participants | 82 Participants |
| Sex: Female, Male Male | 82 Participants | 96 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 133 |
| other Total, other adverse events | 0 / 127 | 2 / 133 |
| serious Total, serious adverse events | 0 / 127 | 0 / 133 |
Outcome results
Primary
Decreased Average Minute Ventilation (MV)
The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sugammadex | Decreased Average Minute Ventilation (MV) | 20 Participants |
| Placebo | Decreased Average Minute Ventilation (MV) | 26 Participants |
Primary
Decreased Minute Ventilation (MV)
The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sugammadex | Decreased Minute Ventilation (MV) | 20 Participants |
| Placebo | Decreased Minute Ventilation (MV) | 26 Participants |
Secondary
Train of Four (TOF) Ratio
The number of subjects to have a normal TOF ratio (\>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)
Time frame: upon PACU discharge, approximately 8 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sugammadex | Train of Four (TOF) Ratio | 42 Participants |
| Placebo | Train of Four (TOF) Ratio | 29 Participants |