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Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
Phase 4 trial testing Rocuronium in Surgery in 84 participants. Completed in 30 July 2021.
| Lead sponsor | West Virginia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 1 May 2019 |
| Primary completion | 30 July 2021 |
| Estimated completion | 30 July 2021 |
| Sites | 1 location across United States |
West Virginia University
Adults 18 to 70, any sex, with Surgery or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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".
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 10.4 | ± 5.9 |
| Sugammadex | 6 | ± 4.7 |
Heart rate post-reversal prior to extubation
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 81.5385 | ± 13.6302 |
| Sugammadex | 81.1622 | ± 10.9735 |
Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 105.6 | ± 18.2067 |
| Sugammadex | 112.1 | ± 14.939 |
Tidal volume post-reversal prior to extubation
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 1.16 | ± 0.5957 |
| Sugammadex | 1.0975 | ± 0.4977 |
Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 1.4609 | ± 0.9968 |
| Sugammadex | 1.416 | ± 0.8466 |
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. Aspirat
| Group | Value | 95% CI |
|---|---|---|
| Neostigmine/Glycopyrrolate | 29 | |
| Sugammadex | 33 | |
| Neostigmine/Glycopyrrolate | 4 | |
| Sugammadex | 2 | |
| Neostigmine/Glycopyrrolate | 3 | |
| Sugammadex | 0 |
Time frame: Adverse events were collected for a 24 hour period. The 24 hour period begins when surgery stop is designated in the electronic medical record.. Reporting threshold: 2.8%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Neostigmine/Glycopyrrolate | Sugammadex |
|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | — | — |
| R ICA Stroke | Vascular disorders | — | — |
| R MCA Stroke | Vascular disorders | — | — |
| Reaction | System | Neostigmine/Glycopyrrolate | Sugammadex |
|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | — | — |
| Incomplete Right Bundle Branch Block | Cardiac disorders | — | — |
Most-reported serious reactions: Myocardial Infarction, R ICA Stroke, R MCA Stroke.
Data from ClinicalTrials.gov NCT03939923 adverse events section.
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).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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