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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| University of Texas | OTHER |
| Respiratory Motion, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated. |
|
| Placebo | Placebo Comparator | Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15---30 minutes after Post-anesthesia care unit (PACU) arrival |
| 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. | 15---30 minutes after Post-anesthesia care unit (PACU) arrival |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | upon PACU discharge, approximately 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Ross Renew, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| The University of Texas, UTHealth |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 15---30 minutes after Post-anesthesia care unit (PACU) arrival |
|
Adverse Events were collected from baseline to end of study (discharged from the recovery room), approximately 8 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Catherization post surgery - Stent placed | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Ross Renew, M.D. | Mayo Clinic | 904-956-3328 | Renew.J@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2017 | May 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Drug | Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated. |
|
| Houston |
| Texas |
| 77030 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline race/ethnicity was not collect or provided for 57 subjects in the Sugammadex arm. Baseline race/ethnicity was not collect or provided for 59 subjects in the Placebo arm. Could not use Race (NIH/OMB) pre-structured Baseline Measure, as there is not a Hispanic or Latino in that option. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| 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. | Posted | Count of Participants | Participants | 15---30 minutes after Post-anesthesia care unit (PACU) arrival |
|
|
|
| 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) | Posted | Count of Participants | Participants | upon PACU discharge, approximately 8 hours |
|
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | 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. | 0 | 133 | 0 | 133 | 2 | 133 |
| Extended intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |