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The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).
Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.
Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.
Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neostigmine with glycopyrrolate | Active Comparator | Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery |
|
| Sugammadex | Experimental | Sugammadex 4 mg/kg at the end surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | Neostigmine injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent | The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent. | within 90 minutes after endotracheal extubation |
| TOF Ratio at 90 Min | TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis. | at 90 minutes after the administration of the reversal agent |
| Measure | Description | Time Frame |
|---|---|---|
| The Time for Extubation After Administration of Reversal Agents | Time from administration of reversal agent to tracheal extubation | Up to 4 hours after administration of reversal agents |
| Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34032663 | Derived | Farag E, Rivas E, Bravo M, Hussain S, Argalious M, Khanna S, Seif J, Pu X, Mao G, Bain M, Elgabaly M, Esa WAS, Sessler DI. Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-Based Neurointerventional Procedures: A Randomized Trial. Anesth Analg. 2021 Jun 1;132(6):1666-1676. doi: 10.1213/ANE.0000000000005533. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neostigmine With Glycopyrrolate | Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery Neostigmine: Neostigmine injection Glycopyrrolate: Glycopyrrolate injection |
| FG001 | Sugammadex | Sugammadex 4 mg/kg at the end surgery Sugammadex: Sugammadex injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neostigmine With Glycopyrrolate | Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery Neostigmine: Neostigmine injection Glycopyrrolate: Glycopyrrolate injection |
| BG001 | Sugammadex |
| 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 | Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent | The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent. | Posted | Median | 95% Confidence Interval | minutes | within 90 minutes after endotracheal extubation |
|
Until hospital discharge or 30 days after surgery, which came first
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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 With Glycopyrrolate | Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery Neostigmine: Neostigmine injection Glycopyrrolate: Glycopyrrolate injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ehab Farag | Cleveland Clinic Foundation | 216 444-7550 | FARAGE@ccf.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 | Apr 17, 2017 | Mar 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Glycopyrrolate |
| Drug |
Glycopyrrolate injection |
|
| Sugammadex | Drug | Sugammadex injection |
|
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. |
| from baseline to 90 minutes after the administration of the reversal agent |
| Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s | The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. | from baseline to 90 minutes after the administration of reversal agent |
Sugammadex 4 mg/kg at the end surgery Sugammadex: Sugammadex injection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| ASA | American Society of Anesthesiologists physical status is to assess and communicate a patient's pre-anesthesia medical co-morbidities. This status has a grade from I to VI, where I mean a normal healthy patient and VI means a declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| Arterial hypertension | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Chronic pulmonary disease | Count of Participants | Participants |
|
| Obstructive sleep apnea | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Myocardial infarction | Count of Participants | Participants |
|
| Ischemic heart disease | Count of Participants | Participants |
|
| Neurologic diseases | Count of Participants | Participants |
|
| Chronic pain requiring opioids | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Current recreational drug user | Count of Participants | Participants |
|
| Alcohol abuse | Count of Participants | Participants |
|
| Cancer | Count of Participants | Participants |
|
| No medical history | Count of Participants | Participants |
|
| Intraoperative remifentanil | Intraoperative remifentanil use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Count of Participants | Participants |
|
| Intraoperative remifentanil, μg | Intraoperative remifentanil use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Median | Inter-Quartile Range | μg |
|
| Intraoperative fentanyl | Intraoperative fentanyl use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Count of Participants | Participants |
|
| Intraoperative fentanyl, mg | Intraoperative fentanyl use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Median | Inter-Quartile Range | mg |
|
| Intraoperative propofol, mg | Intraoperative propofol use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Median | Inter-Quartile Range | mg |
|
| Intraoperative midazolam, mg | Intraoperative midazolam use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Median | Inter-Quartile Range | mg |
|
| Intraoperative Phenylephrine | Intraoperative phenylephrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Count of Participants | Participants |
|
| Intraoperative Ephedrine | Intraoperative ephedrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Count of Participants | Participants |
|
| Intraoperative Norepinephrine | Intraoperative norepinephrine use could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Count of Participants | Participants |
|
| Time-weighted average minimum alveolar concentration | time-weighted average minimum alveolar concentration could be related to our outcome and it was before the treatment, thus we think it was important to report it as baseline measures. | Median | Inter-Quartile Range | percent at 1 atmosphere |
|
Sugammadex 4 mg/kg at the end surgery Sugammadex: Sugammadex injection |
|
|
|
| Primary | TOF Ratio at 90 Min | TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis. | Eight patients were removed due to missing TOF at 90 min or TOF count not larger than 4. | Posted | Median | Inter-Quartile Range | ratio | at 90 minutes after the administration of the reversal agent |
|
|
|
|
| Secondary | The Time for Extubation After Administration of Reversal Agents | Time from administration of reversal agent to tracheal extubation | Posted | Median | 95% Confidence Interval | minutes | Up to 4 hours after administration of reversal agents |
|
|
|
|
| Secondary | Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s | The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. | There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes. | Posted | Mean | Standard Deviation | cm/s | from baseline to 90 minutes after the administration of the reversal agent |
|
|
|
|
| Secondary | Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s | The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. | There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes. | Posted | Mean | Standard Deviation | cm/s | from baseline to 90 minutes after the administration of reversal agent |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Sugammadex | Sugammadex 4 mg/kg at the end surgery Sugammadex: Sugammadex injection | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009861 |
| Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |