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The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has now become mainstay, especially with the advent of minimally invasive procedures .
To facilitate optimal recovery after extubation; muscle strength is vital to prevent reintubation, improved deglutition and quicker transition to lower oxygen requirements, and better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of care. Several studies have shown residual muscle weakness after full reversal with neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide superior muscle strength, which optimizes respiratory function thereby preventing atelectasis, hypoxia and potentially avoiding reintubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neostigmine/Glycopyrrolate | Active Comparator | Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). |
|
| Sugammadex | Active Comparator | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on train of four (TOF) watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Extubation | Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation". | 0 minutes of study drug to 3 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate post-reversal prior to extubation | 0 minutes to 2 hours after study drug administration |
| Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal) | Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation | Oxygen saturation post-extubation | 30 minutes post-extubation |
| Post-extubation Oxygen Requirements | Post-extubation Oxygen requirements in subsequent 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25173117 | Background | Badhwar V, Esper S, Brooks M, Mulukutla S, Hardison R, Mallios D, Chu D, Wei L, Subramaniam K. Extubating in the operating room after adult cardiac surgery safely improves outcomes and lowers costs. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3101-9.e1. doi: 10.1016/j.jtcvs.2014.07.037. Epub 2014 Jul 31. | |
| 28711332 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neostigmine/Glycopyrrolate | Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Neostigmine: Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) Glycopyrrolate: Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) |
| 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 25, 2020 |
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Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage).
Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
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The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
| Neostigmine | Drug | Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) |
|
| Glycopyrrolate | Drug | Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) |
|
| Sugammadex | Drug | Reversal with Sugammadex (2mg/kg) |
|
| 0 minutes to 2 hours after study drug administration |
| Tidal Volume | Tidal volume post-reversal prior to extubation | between 30 minutes to 1 hour after extubation |
| Peak Flow Rate | Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins | 30-60 minutes post-extubation |
| Swallowing Capacity | In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking. | Between 30 and 60 minutes post-extubation |
| 2 hours post-extubation |
| Length of Stay Cardiac Intensive Care Unit | Length of stay in the cardiac intensive care from onset of reversal drugs | 0 days after study drug to 100 days after study drug |
| Reintubation Incidence | Reintubation incidence in the first 24 hours post-extubation | 24 hours post-extubation |
| Occurrence of Postoperative Respiratory Complications | Postoperative respiratory complication including re-intubation | 0 hours after study drug to 24 hours after study drug |
| Occurrence of Postoperative Cardiac Complications | Postoperative cardiac complications including myocardial infarction, arrythmias | from 0 hours after study drug to 2 hours after study drug |
| Subramaniam K, DeAndrade DS, Mandell DR, Althouse AD, Manmohan R, Esper SA, Varga JM, Badhwar V. Predictors of operating room extubation in adult cardiac surgery. J Thorac Cardiovasc Surg. 2017 Nov;154(5):1656-1665.e2. doi: 10.1016/j.jtcvs.2017.05.107. Epub 2017 Jun 13. |
| 26448469 | Background | Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865. |
| 27496655 | Background | Murphy GS, Kopman AF. "To Reverse or Not To Reverse?": The Answer Is Clear! Anesthesiology. 2016 Oct;125(4):611-4. doi: 10.1097/ALN.0000000000001280. No abstract available. |
| 20980910 | Background | Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d. |
| 27543551 | Background | Boon M, Martini C, Broens S, van Rijnsoever E, van der Zwan T, Aarts L, Dahan A. Improved postoperative oxygenation after antagonism of moderate neuromuscular block with sugammadex versus neostigmine after extubation in 'blinded' conditions. Br J Anaesth. 2016 Sep;117(3):410-1. doi: 10.1093/bja/aew246. No abstract available. |
| 23665915 | Background | Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95. |
| 20935005 | Background | Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8. |
| 27484887 | Background | Park ES, Lim BG, Lee WJ, Lee IO. Sugammadex facilitates early recovery after surgery even in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: a single-center retrospective study. BMC Anesthesiol. 2016 Aug 2;16(1):48. doi: 10.1186/s12871-016-0221-2. |
| 20688009 | Background | Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Craig D, Hunter J, Wilson J, Sculpher M, Woolacott N. Sugammadex for the reversal of muscle relaxation in general anaesthesia: a systematic review and economic assessment. Health Technol Assess. 2010 Jul;14(39):1-211. doi: 10.3310/hta14390. |
| 20937718 | Background | Chambers D, Paulden M, Paton F, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex for reversal of neuromuscular block after rapid sequence intubation: a systematic review and economic assessment. Br J Anaesth. 2010 Nov;105(5):568-75. doi: 10.1093/bja/aeq270. Epub 2010 Oct 11. |
| 41437213 | Derived | Ellison MB, Statler A, Grose B, Sloyer D, Hayanga H, Ellison PR, Funke C. Reversal of neuromuscular blockade after coronary artery bypass grafting: a randomized control trial. BMC Anesthesiol. 2025 Dec 23;25(1):612. doi: 10.1186/s12871-025-03456-6. |
| FG001 | Sugammadex | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Sugammadex: Reversal with Sugammadex (2mg/kg) |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neostigmine/Glycopyrrolate | Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Neostigmine: Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) Glycopyrrolate: Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) |
| BG001 | Sugammadex | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Sugammadex: Reversal with Sugammadex (2mg/kg) |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 | Time to Extubation | Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart "procedure stop." The definition for "time to extubation" is from the time the investigators chart "procedure stop" to the time of "extubation". | Posted | Mean | Standard Deviation | Minutes | 0 minutes of study drug to 3 days after study drug administration |
|
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| |||||||||||||||||||||||||||||
| Secondary | Heart Rate | Heart rate post-reversal prior to extubation | Posted | Mean | Standard Deviation | beats per minute | 0 minutes to 2 hours after study drug administration |
| |||||||||||||||||||||||||||||||
| Secondary | Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal) | Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea | Posted | Mean | Standard Deviation | mmHg | 0 minutes to 2 hours after study drug administration |
| |||||||||||||||||||||||||||||||
| Secondary | Tidal Volume | Tidal volume post-reversal prior to extubation | Posted | Mean | Standard Deviation | Liters | between 30 minutes to 1 hour after extubation |
| |||||||||||||||||||||||||||||||
| Secondary | Peak Flow Rate | Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins | Posted | Mean | Standard Deviation | L/min | 30-60 minutes post-extubation |
| |||||||||||||||||||||||||||||||
| Secondary | Swallowing Capacity | In the intensive care unit: If the patient awake and alert, is able to be positioned, can cough when asked, able to follow command to lick top and bottom lip, and is able to breathe freely then a registered nurse bedside swallowing/dysphagia screen is performed at a time point somewhere between 30 and 60 minutes following the operating room extubation. To perform the screen, a teaspoon is used to place distilled water on each subject's tongue, 3 mL each time 2 consecutive times. Then 3 ounces of water intake. The patient is asked to swallow the water to evaluate the swallowing ability. Aspiration of fluid (choking) subjectively divided into 4 categories: normal, no choking or hoarse voice after swallowing; mild, no choking but slight hoarseness of voice; moderate, no choking but a clearly identifiable hoarseness of voice; severe, choking. | Posted | Count of Participants | Participants | Between 30 and 60 minutes post-extubation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Oxygen Saturation | Oxygen saturation post-extubation | Not Posted | 30 minutes post-extubation | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Post-extubation Oxygen Requirements | Post-extubation Oxygen requirements in subsequent 2 hours | Not Posted | 2 hours post-extubation | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Length of Stay Cardiac Intensive Care Unit | Length of stay in the cardiac intensive care from onset of reversal drugs | Not Posted | 0 days after study drug to 100 days after study drug | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Reintubation Incidence | Reintubation incidence in the first 24 hours post-extubation | Not Posted | 24 hours post-extubation | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Occurrence of Postoperative Respiratory Complications | Postoperative respiratory complication including re-intubation | Not Posted | 0 hours after study drug to 24 hours after study drug | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Occurrence of Postoperative Cardiac Complications | Postoperative cardiac complications including myocardial infarction, arrythmias | Not Posted | from 0 hours after study drug to 2 hours after study drug | Participants |
Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record.
Defined as any unfavorable and unintended medical occurrence, symptom, or disease temporally associated with the use of a medical treatment of the subjects whether it is associated or related to the medical treatment. The Principal Investigator will identify and make adverse events assessments. Adverse events and severe adverse events such as pneumonia, arrhythmia, and reintubation within 24 hours will be compared in both groups.
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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 | Neostigmine/Glycopyrrolate | Group 1: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Neostigmine: Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) Glycopyrrolate: Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage) | 0 | 36 | 2 | 36 | 1 | 36 |
| EG001 | Sugammadex | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Sugammadex: Reversal with Sugammadex (2mg/kg) | 0 | 35 | 1 | 35 | 1 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | ST Segment Elevation (on EKG) Myocardial Infarction unrelated to study |
| |
| R ICA Stroke | Vascular disorders | Systematic Assessment | Right Internal Carotid Artery Cerebrovascular Stroke unrelated to study |
| |
| R MCA Stroke | Vascular disorders | Systematic Assessment | Right Middle Cerebral Artery Cerebrovascular Stroke unrelated to study |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Atrial Fibrillation not related to study |
| |
| Incomplete Right Bundle Branch Block | Cardiac disorders | Systematic Assessment | Incomplete Right Bundle Brach Block not related to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research in Department of Anesthesiology | West Virginia University | 304-598-4122 | david.scalzo@hsc.wvu.edu |
| Apr 30, 2023 |
| Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| OG001 | Sugammadex | Group 2: Intubation with rocuronium at 1.0-1.2 mg/kg (vitals maintained within 20% of baseline). Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure to maintain 1-2 twitches on TOF watch monitor reading recorded every 15 minutes. Group 2 (treatment) will receive reversal with Sugammadex (2mg/kg). Rocuronium: Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure. Sugammadex: Reversal with Sugammadex (2mg/kg) |
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