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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular blockade reversed with neostigmine/gly | Experimental |
| |
| Neuromuscular blockade reversed with sugammadex | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine+glycopyrrolate | Drug | At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| German Echeverry, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Commack |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neuromuscular Blockade Reversed With Neostigmine/Gly | Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate |
| FG001 | Neuromuscular Blockade Reversed With Sugammadex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 17, 2019 |
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| Sugammadex | Drug | At the conclusion of surgery neuromuscular blockade reversed with sugammadex |
|
| Commack |
| New York |
| 11725 |
| United States |
| Memoral Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neuromuscular Blockade Reversed With Neostigmine/Gly | Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate |
| BG001 | Neuromuscular Blockade Reversed With Sugammadex | Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | 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. | Posted | Median | Inter-Quartile Range | hours | 1 day |
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|
1 year
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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 | Neuromuscular Blockade Reversed With Neostigmine/Gly | Neostigmine+glycopyrrolate: At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate | 14 | 100 | 2 | 100 | 0 | 100 |
| EG001 | Neuromuscular Blockade Reversed With Sugammadex | Sugammadex: At the conclusion of surgery neuromuscular blockade reversed with sugammadex | 16 | 101 | 2 | 101 | 0 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Kidney anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. German Echeverry, MD | Memorial Sloan Kettering Cancer Center | 212-639-8865 | echeverg@mskcc.org |
| Feb 3, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|