SurgeryPhase 3NCT05801679

Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo

A Phase 3 study testing Sugammadex in people with Surgery, run by Endeavor Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 90 years
Conditions the study is for: Surgery
What is being tested?: Sugammadex
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 3 Jul 2023to 11 Jul 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must be an elective or urgent cardiac surgical patient undergoing cardiopulmonary bypass at NorthShore University HealthSystem.
Male or female subject aged 21 to 90 years, at the time of consent.
Subject who can consent in English.
Subjects who are eligible for fast track extubation as defined by those patients who plan on being extubated within 24 hours of the end of surgery and optimally within the 6-hour STS benchmark time from end of surgery.

Who cannot join

Subjects having emergency cardiac surgery.
Subjects who cannot consent in English.
Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
Subjects with neuromuscular disorders.
Subjects on home oxygen.
Subjects who have known allergies or reactions to rocuronium or sugammadex.

Show all 10Show fewer

Subjects with anticipated need for prolonged intubation by the clinical treating team.
Subjects with a history of opioid abuse.
Subjects on mechanical circulatory support.
Subjects who have end stage renal disease requiring dialysis.

Trial locations and contacts

1 site in 1 country.

United States1 site

NorthShore University HealthSystem
Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: A Prospective Randomized Blinded Controlled Trial Comparing Clinical Outcomes in Cardiac Surgical Patients Who Receive Sugammadex vs. Placebo

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.

Read the detailed description

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.

Conditions: Surgery
Being tested: Sugammadex, Placebo
Keywords: Sugammadex, Cardiac Surgical Patients, Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SugammadexDrug
Also called MK-8616
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.
PlaceboOther
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.

Study groups in NCT05801679
Study group	Role	What they receive
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). Receives: Drug: Sugammadex
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). Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: within 6 hours of end of surgery

Secondary outcomes (11)

Time to First Extubation
Time to first extubation from end of surgery in each group will be recorded.
Measured: Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)
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.
Measured: 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.
Measured: At time of extubation
ICU Length of Stay
ICU length of stay (hours) in each group will be recorded.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: At extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 202311 Jul 2025

First posted6 Apr 2023
Study start3 Jul 2023
Primary completion11 Jul 2025
Study completion11 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05801679
Sponsor's protocol ID: EH23-005
Status last verified: Apr 2026
First submitted: 30 Jan 2023
Last updated: 4 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: We do not plan to make IPD available to other researchers.

Publications

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.
PubMed 35193778
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.
PubMed 30464493
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.
PubMed 27154151
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.
PubMed 29395821
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.
PubMed 12456412
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.
PubMed 20442260
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.
PubMed 17156221
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.
PubMed 26936365
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.
PubMed 27871504
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.
PubMed 35759402
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.
PubMed 35094928
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.
PubMed 32962936
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.
PubMed 32464476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Blinded Controlled Trial Comparing Clinical Outcomes in Cardiac Surgical Patients Who Receive Sugammadex vs. Placebo
ClinicalTrials.gov ID: NCT05801679
Acronym / sponsor ID: EH23-005
Conditions: Surgery
Keywords: Sugammadex, Cardiac Surgical Patients, Anesthesia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Endeavor HealthUniversity, hospital or other
Study start: 3 Jul 2023 (actual)
Primary completion: 11 Jul 2025 (actual)
Study completion: 11 Jul 2025 (actual)
First posted: 6 Apr 2023 (actual)
Results: Posted 4 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Sugammadex	Experimental	Drug: SugammadexSingle 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	Other: PlaceboSingle 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).

Who may qualify

Ages: 21 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject must be an elective or urgent cardiac surgical patient undergoing cardiopulmonary bypass at NorthShore University HealthSystem.
Male or female subject aged 21 to 90 years, at the time of consent.
Subject who can consent in English.
Subjects who are eligible for fast track extubation as defined by those patients who plan on being extubated within 24 hours of the end of surgery and optimally within the 6-hour STS benchmark time from end of surgery.

Key exclusion criteria (10 listed)

Subjects having emergency cardiac surgery.
Subjects who cannot consent in English.
Subjects who are not eligible to be extubated within 24 hours of the end of surgery.
Subjects with neuromuscular disorders.
Subjects on home oxygen.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SugammadexAlso: MK-8616Fifteen 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.	Drug	Sugammadex
PlaceboFifteen 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.	Other	Placebo

Primary outcome

Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria
Time frame: within 6 hours of end of surgery
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.

11 secondary outcomes

Time to First Extubation
Time frame: Intraoperative (The time (in hours) it takes to remove the breathing tube immediately at the end of surgery.)
Final Train-of-Four Ratio
Time frame: At time of extubation
Final Train-of-Four Ratio
Time frame: At time of extubation
ICU Length of Stay
Time frame: From time of postoperative ICU admission to time of ICU discharge
Hospital Length of Stay
Time frame: From time of hospital admission to time of hospital discharge
Incidence of Reintubation Post-extubation
Time frame: up to 1 week
Incidence of Post-extubation Pneumonia
Time frame: up to 1 week
Post-Extubation Hypoxemia
Time frame: Average of 6 hour intervals over first 24 hours post-operatively
Post-Extubation Hypoxemia
Time frame: 24 hours post-operatively
Nursing Perception Questionnaire of Cardiac Surgical Subjects' ICU Quality of Recovery
Time frame: Within first 24 hours of ICU length of stay
Final Train-of-Four Ratio Proportion Greater Than or Equal to 0.9
Time frame: At extubation

Results and safety

Results posted to the registry on 4 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sugammadex	33	32
Placebo	35	32

Primary outcome: Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria

Time frame: within 6 hours of end of surgery. Count of participants. Unit: Participants

Measure	Sugammadex n = 32	Placebo n = 32
Value	31	31

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of study enrollment to time of hospital discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugammadex	2 of 32 (6.3%)	1 of 32 (3.1%)	0 of 32
Placebo	1 of 32 (3.1%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): 1. Single hospital system 2. Lack of inclusion of emergent cases and non-fast-track extubation 3. Relatively small sample size 4. Data collected on rNMB complications were largely limited to clinical patient outcomes in the first 24 hours post-extubation 5. Hypoxemia data collection was limited to every 6 hours for 24 hours postoperatively 6. Inequality of intraoperative parameters between sugammadex and placebo groups

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35193778Chacon 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.
Results publication: PubMed 30464493Kotfis 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.
Results publication: PubMed 27154151Cove 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.
Results publication: PubMed 29395821Goeddel 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.
Results publication: PubMed 12456412Murphy 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.
Results publication: PubMed 20442260Murphy 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.
Results publication: PubMed 17156221Maybauer 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.
Results publication: PubMed 26936365Roy 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.
Results publication: PubMed 27871504Carron 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.
Results publication: PubMed 35759402Ebert 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.
Results publication: PubMed 35094928Fischer 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.
Results publication: PubMed 32962936Li 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.
Individual participant dataSharing planned: No. We do not plan to make IPD available to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Greenberg, MD principal investigator

Endeavor Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sugammadex in people with Surgery, run by Endeavor Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Society of Thoracic Surgery (STS) Quality Benchmark of Early Extubation Criteria (time frame: within 6 hours of end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05801679, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.