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This is a prospective randomized blinded controlled trial that will enroll 175 subjects undergoing cardiopulmonary bypass at NorthShore University HealthSystem. The purpose of this study is to compare clinical outcomes in elective and urgent cardiac surgical patients at NorthShore University HealthSystem when receiving sugammadex, a common neuromuscular blockade reversal drug given after surgery and before the breathing tube is removed vs. those patients who do not receive sugammadex (placebo) group. The Investigators will compare the following outcomes in both the sugammadex and placebo groups during patients hospital stay: # of patients who have the breathing tube removed within 6 hour of the end of surgery, time it takes to remove the breathing tube after surgery, ICU and hospital length of stay, cost of the ICU stay, time to achieve a train of four ratio of > or equal to 0.9, whether patients develop pneumonia or not, whether they require the breathing tube to be replaced during their hospital stay and to compare the nursing perception of patients recovery within first 24 hours of their ICU stay.
At the conclusion of many cardiac surgical cases requiring cardiopulmonary bypass, patients are typically transferred to the intensive care unit (ICU) with the endotracheal tube remaining in the airway postoperatively without routine reversal of neuromuscular blockade (NMB). This blockade is typically metabolized by the liver/kidney and then patients are liberated from the ventilator in the ICU afterwards. The proposed reason for this strategy is to reduce the potential risk of rebleeding or arrhythmias due to a sympathetic response from patients. A survey among 495 cardiac anesthesiologists in the U.S. in 2002 suggested that only 9% of anesthesiologists routinely reverse NMB in these patients prior to extubation. However, the lack of reversal drug use among any surgical patient population could result in residual neuromuscular blockade, which is defined by a train of four ratio ≥0.9. Patients who do not meet this level of neuromuscular recovery are at risk for a number of adverse outcomes including hypoxemia, airway obstruction, impaired swallowing function, increased risk for aspiration, prolonged length of stay, postoperative respiratory complications, and need for reintubation. The data regarding residual neuromuscular blockade in cardiac surgical patients is limited. A prospective observational cohort of 50 cardiac surgical patients, suggested that 66% of patients had significant residual neuromuscular blockade within 1 hour postoperatively. Prolonged intubation can lead to unwanted adverse outcomes such as pneumonia. Our clinical practice at NorthShore University HealthSystem for cardiac surgical patients changed as it relates to managing neuromuscular blockade. Prior to 2019, the clinical care team (cardiac surgery, intensive care, nursing, and anesthesia) did not routinely discuss dosing or reversal of neuromuscular blockade during the ICU handoff of patients. Anesthesia professionals also did not routinely reverse neuromuscular blockade in post-cardiac surgical patients. In the latter half of 2019, the care team developed a multidisciplinary handoff checklist, which includes discussion regarding the last dose of NMB, and whether the patient was given reversal. The anesthesia professionals changed practice to meet or exceed the Society of Thoracic Surgeons (STS) early extubation national benchmark within 6 hours of the end of surgery. Therefore, the investigators hypothesize that by reversing cardiac surgery patients with sugammadex in the ICU, the investigators will be able to achieve the STS early extubation criteria more frequently and it will also result in reduced ICU, hospital length of stay and cost of ICU stay. The investigators also believe it will result in less reintubation and pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). |
|
| Placebo | Placebo Comparator | Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria | Will compare the difference in the number of subjects who receive sugammadex and meet the STS 6-hour extubation criteria from the end of surgery vs. those that do not receive neuromuscular blockade reversal. The Society of Thoracic Surgery defines early extubation as extubation within six hours of completion of cardiac surgery and uses this as a reportable benchmark. | within 6 hours of end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Extubation | Time to first extubation from end of surgery in each group will be recorded. | Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.) |
| Final Train-of-Four Ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Greenberg, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35193778 | Result | Chacon M, Markin NW. Early is Good, But is Immediate Better? Considerations in Fast-Track Extubation After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2022 May;36(5):1265-1267. doi: 10.1053/j.jvca.2022.01.031. Epub 2022 Jan 25. No abstract available. | |
| 30464493 | Result | Kotfis K, Szylinska A, Listewnik M, Lechowicz K, Kosiorowska M, Drozdzal S, Brykczynski M, Rotter I, Zukowski M. Balancing intubation time with postoperative risk in cardiac surgery patients - a retrospective cohort analysis. Ther Clin Risk Manag. 2018 Nov 5;14:2203-2212. doi: 10.2147/TCRM.S182333. eCollection 2018. |
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We do not plan to make IPD available to other researchers.
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Patients undergoing elective or urgent open cardiac surgery on cardiopulmonary bypass were consented for participation 2023 through 2025. Participants were recruited from the Cardiac Surgical Clinic at Endeavor Health and seen in the ICU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| FG001 | Placebo | Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| 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 | Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria | Will compare the difference in the number of subjects who receive sugammadex and meet the STS 6-hour extubation criteria from the end of surgery vs. those that do not receive neuromuscular blockade reversal. The Society of Thoracic Surgery defines early extubation as extubation within six hours of completion of cardiac surgery and uses this as a reportable benchmark. | Posted | Count of Participants | Participants | within 6 hours of end of surgery |
|
From time of study enrollment to time of hospital discharge
All events that occurred have been reported.
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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 | Single intravenous (IV) bolus of sugammadex at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Sugammadex: Fifteen minutes after ICU arrival, subjects will be administered sugammadex (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Level of Care Required | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iliofemoral thrombectomy | Vascular disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Greenberg | Endeavor Health | 847-570-2760 | anesthesiaresearch@endeavorhealth.org |
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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 | May 7, 2025 | Dec 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2025 | Dec 4, 2025 | ICF_001.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 | Other | Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
|
The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9.
In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis.
| At time of extubation |
| Final Train-of-Four Ratio | The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9 In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis. | At time of extubation |
| ICU Length of Stay | ICU length of stay (hours) in each group will be recorded. | From time of postoperative ICU admission to time of ICU discharge |
| Hospital Length of Stay | Hospital length of stay (days) in each group will be recorded. | From time of hospital admission to time of hospital discharge |
| Incidence of Reintubation Post-extubation | The incidence of reintubation post-extubation in each group will be collected during the current hospital stay. | up to 1 week |
| Incidence of Post-extubation Pneumonia | The incidence of post-extubation pneumonia in each group will be collected during the current hospital stay | up to 1 week |
| Post-Extubation Hypoxemia | Post-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 < 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation. | Average of 6 hour intervals over first 24 hours post-operatively |
| Post-Extubation Hypoxemia | Hypoxemia information regarding the first 24 hours post operatively was retrospectively collected post-discharge and was defined in accordance with the Berlin criteria. | 24 hours post-operatively |
| Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery | The nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected. (A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied) | Within first 24 hours of ICU length of stay |
| Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9 | The number of participants that achieved a qTOFR greater than or equal to 0.9 was compared between the sugammadex and placebo arms. In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis. | At extubation |
| 27154151 | Result | Cove ME, Ying C, Taculod JM, Oon SE, Oh P, Kollengode R, MacLaren G, Tan CS. Multidisciplinary Extubation Protocol in Cardiac Surgical Patients Reduces Ventilation Time and Length of Stay in the Intensive Care Unit. Ann Thorac Surg. 2016 Jul;102(1):28-34. doi: 10.1016/j.athoracsur.2016.02.071. Epub 2016 May 4. |
| 29395821 | Result | Goeddel LA, Hollander KN, Evans AS. Early Extubation After Cardiac Surgery: A Better Predictor of Outcome than Metric of Quality? J Cardiothorac Vasc Anesth. 2018 Apr;32(2):745-747. doi: 10.1053/j.jvca.2017.12.037. Epub 2018 Jan 2. No abstract available. |
| 12456412 | Result | Murphy GS, Szokol JW, Vender JS, Marymont JH, Avram MJ. The use of neuromuscular blocking drugs in adult cardiac surgery: results of a national postal survey. Anesth Analg. 2002 Dec;95(6):1534-9, table of contents. doi: 10.1097/00000539-200212000-00012. |
| 20442260 | Result | Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. |
| 17156221 | Result | Maybauer DM, Geldner G, Blobner M, Puhringer F, Hofmockel R, Rex C, Wulf HF, Eberhart L, Arndt C, Eikermann M. Incidence and duration of residual paralysis at the end of surgery after multiple administrations of cisatracurium and rocuronium. Anaesthesia. 2007 Jan;62(1):12-7. doi: 10.1111/j.1365-2044.2006.04862.x. |
| 26936365 | Result | Roy M, Morissette N, Girard M, Robillard N, Beaulieu P. Postoperative awake paralysis in the intensive care unit after cardiac surgery due to residual neuromuscular blockade: a case report and prospective observational study. Can J Anaesth. 2016 Jun;63(6):725-30. doi: 10.1007/s12630-016-0606-1. Epub 2016 Mar 2. |
| 27871504 | Result | Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4. |
| 35759402 | Result | Ebert TJ, Cumming CE, Roberts CJ, Anglin MF, Gandhi S, Anderson CJ, Stekiel TA, Gliniecki R, Dugan SM, Abdelrahim MT, Klinewski VB, Sherman K. Characterizing the Heart Rate Effects From Administration of Sugammadex to Reverse Neuromuscular Blockade: An Observational Study in Patients. Anesth Analg. 2022 Oct 1;135(4):807-814. doi: 10.1213/ANE.0000000000006131. Epub 2022 Sep 15. |
| 35094928 | Result | Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25. |
| 32962936 | Result | Li L, Jiang Y, Zhang W. Sugammadex for Fast-Track Surgery in Children Undergoing Cardiac Surgery: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2021 May;35(5):1388-1392. doi: 10.1053/j.jvca.2020.08.069. Epub 2020 Sep 3. |
| 32464476 | Result | Yan P, Wu X, Cai F, Chen Y, Huang Y, Li G, Lai K. Efficacy and safety of sugammadex in anesthesia of cardiac surgery: A retrospective study. J Clin Anesth. 2020 Oct;65:109845. doi: 10.1016/j.jclinane.2020.109845. Epub 2020 May 26. No abstract available. |
| BG001 | Placebo | Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| ASA Status | The American Society of Anesthesiologists (ASA) Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical comorbidities and estimate perioperative risk. ASA I are normal healthy patients. ASA II patients are defined as having mild systemic disease. ASA III patients have severe systemic disease. ASA IV patients have severe systemic disease that is a constant threat to life. ASA V patients have severe, life threatening conditions. ASA VI patients are declared brain-dead and are organ donation participants. | Count of Participants | Participants |
|
| System Comorbidities | Count of Participants | Participants |
|
| Surgery Type | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| OG001 | Placebo | Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. |
|
|
| Secondary | Time to First Extubation | Time to first extubation from end of surgery in each group will be recorded. | Posted | Mean | Standard Deviation | hours | Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.) |
|
|
|
| Secondary | Time to First Extubation | Time to first extubation from end of surgery in each group will be recorded. | Posted | Median | Inter-Quartile Range | hours | Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.) |
|
|
|
| Secondary | Final Train-of-Four Ratio | The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9. In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis. | Posted | Mean | Standard Deviation | ratio | At time of extubation |
|
|
|
| Secondary | Final Train-of-Four Ratio | The final train-of-four ratio was determined at time of extubation using a commercially available quantitative neuromuscular monitor and categorized as greater than or equal to 0.9 or less than 0.9 In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis. | Posted | Median | Inter-Quartile Range | ratio | At time of extubation |
|
|
|
| Secondary | ICU Length of Stay | ICU length of stay (hours) in each group will be recorded. | Posted | Mean | Standard Deviation | hours | From time of postoperative ICU admission to time of ICU discharge |
|
|
|
| Secondary | ICU Length of Stay | ICU length of stay (hours) in each group will be recorded. | Posted | Median | Inter-Quartile Range | hours | From time of postoperative ICU admission to time of ICU discharge |
|
|
|
| Secondary | Hospital Length of Stay | Hospital length of stay (days) in each group will be recorded. | Posted | Mean | Standard Deviation | days | From time of hospital admission to time of hospital discharge |
|
|
|
| Secondary | Hospital Length of Stay | Hospital length of stay (days) in each group will be recorded. | Posted | Median | Inter-Quartile Range | days | From time of hospital admission to time of hospital discharge |
|
|
|
| Secondary | Incidence of Reintubation Post-extubation | The incidence of reintubation post-extubation in each group will be collected during the current hospital stay. | Posted | Count of Participants | Participants | up to 1 week |
|
|
|
| Secondary | Incidence of Post-extubation Pneumonia | The incidence of post-extubation pneumonia in each group will be collected during the current hospital stay | Posted | Count of Participants | Participants | up to 1 week |
|
|
|
| Secondary | Post-Extubation Hypoxemia | Post-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 < 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation. | Posted | Mean | Standard Deviation | Average SPO2/FiO2 ratio | Average of 6 hour intervals over first 24 hours post-operatively |
|
|
|
| Secondary | Post-Extubation Hypoxemia | Post-extubation hypoxemic episodes were defined according to the Berlin criteria where PaO2/FiO2 ratios were approximated using previously validated SpO2/FiO2 ratios every 6 hours for 24 hours post-extubation. SpO2/FiO2 < 235 corresponded to moderate to severe hypoxemia and 235-315 corresponded to mild hypoxemia. Reported ratio values were calculated as the average of data collected (every 6 hours) during the 24-hour period post-extubation. | Posted | Median | Inter-Quartile Range | Average SPO2/FiO2 ratio | Average of 6 hour intervals over first 24 hours post-operatively |
|
|
|
| Secondary | Post-Extubation Hypoxemia | Hypoxemia information regarding the first 24 hours post operatively was retrospectively collected post-discharge and was defined in accordance with the Berlin criteria. | Posted | Number | participants | 24 hours post-operatively |
|
|
|
| Secondary | Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery | The nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected. (A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied) | Posted | Mean | Standard Deviation | units on a scale | Within first 24 hours of ICU length of stay |
|
|
|
| Secondary | Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery | The nursing perception questionnaire of cardiac surgical subjects' ICU quality of recovery within first 24 hours of ICU length of stay will be collected. (A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4= Somewhat satisfied, 5= Very satisfied) | Posted | Median | Inter-Quartile Range | units on a scale | Within first 24 hours of ICU length of stay |
|
|
|
| Secondary | Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9 | The number of participants that achieved a qTOFR greater than or equal to 0.9 was compared between the sugammadex and placebo arms. In order to assess the depth of neuromuscular blockade and recovery from paralyzing anesthesia drugs, a nerve is rapidly stimulated four times creating four muscle twitches. The Train-of-Four ratio is the amplitude of the fourth muscle twitch divided by the amplitude of the first twitch. A TOF Ratio of 0.9 or greater is usually indicative of adequate recovery from muscle paralysis. | Posted | Count of Participants | Participants | At extubation |
|
|
|
| 0 |
| 32 |
| 2 |
| 32 |
| 1 |
| 32 |
| EG001 | Placebo | Single intravenous (IV) bolus of Placebo at 2 mg/kg (Twitch count 2-4 of 4) or 4 mg/kg (twitch count less than 2 of 4). Placebo: Fifteen minutes after ICU arrival, subjects will be administered placebo (2 mg/kg assuming a twitch count of 2-4 of 4 or 4mg/kg assuming a twitch count less than 2 of 4) by the anesthesia provider. Five minutes after administration, a quantitative neuromuscular monitor (TetraGraph, Senzime, Uppsala, Sweden) will be applied and the TOF ratio will be recorded. | 0 | 32 | 1 | 32 | 0 | 32 |
| Re-intubation, mechanical ventilation, iNO | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pericardial effusion and concern for cardiac tamponade | Cardiac disorders | Systematic Assessment |
|
| bilateral pulmonary embolism and deep vein thrombosis with thrombectomy | Vascular disorders | Systematic Assessment |
|
| acute hypoxemic respiratory insufficiency requiring thoracocentesis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| Required BiPAP |
|
| Required HFNC |
|
| Required Either BiPAP or HFNC |
|