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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The investigators propose a single-center, assessor-Blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Fairview Hospital.
The investigators propose a single-center, assessor-blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine. Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who assume anesthesia care will not be blinded to group assignment.
American Society of Anesthesiologists (ASA) physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Fairview Hospital will be included in the study. Patients will be excluded if they have suspected difficult airway, neuromuscular disorders, end-stage renal disease requiring hemodialysis, are allergic to fentanyl, neuromuscular blocking drugs or neuromuscular reversal drugs, or are pregnant or breastfeeding.
Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 1:1 to: 1) reversal by sugammadex; or 2) reversal by neostigmine. Randomization will be stratified by 2 factors: (1) patient's age (older than 60 versus younger than 60) and (2) diagnostic vs. interventional procedures. Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia, thus concealing allocation so long as practical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg/kg sugammadex | Experimental | All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex. |
|
| 0.07 mg/kg neostigmine | Active Comparator | All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 mg/kg sugammadex | Drug | All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex. |
| Measure | Description | Time Frame |
|---|---|---|
| Time required from reversal of neuromuscular block to discharge readiness | To assess the time required from reversal of neuromuscular block to discharge readiness in patients randomized to sugammadex or neostigmine. | First 24 hours after reversal of neuromuscular block |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine. | Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine. | 2 hours of post anesthetic recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabry Ayad, MD | Contact | 216-476-7052 | Saayad@ccf.org | |
| Erica Linna, RN | Contact | 216-633-5073 | Linnae@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Ryu Komatsu, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Fairview Hospital | Recruiting | Cleveland | Ohio | 44111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21704815 | Background | Cotton PB. Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW. Gastrointest Endosc. 2011 Jul;74(1):161-6. doi: 10.1016/j.gie.2011.03.1233. No abstract available. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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A single-center, Assessor-Blinded, parallel group randomized trial
|
| 0.07 mg/kg neostigmine | Drug | All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg). |
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |