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The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugammadex 0.125 | Sugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3 |
| |
| Sugammadex 0.25 | Sugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3 |
| |
| Sugammadex 0.5 | Sugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3 |
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| Sugammadex 1.0 | Sugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3 |
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| Sugammadex 2.0 | Sugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3 |
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| Neostigmine 10 | Neostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to TOF 0.9 after the administration of reversal agent | The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration. | the general anesthesia time 1 hour at least |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of reparalysis | Determining whether patients receiving reversal agent will have a train-to-four ratio <0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure) | approximately 1 hour |
| incidence of adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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people scheduled for elective surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Military Region General Hospital, Department of Anesthesiology | Guangzhou | Guangdong | 510010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20885293 | Background | Schaller SJ, Fink H, Ulm K, Blobner M. Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block. Anesthesiology. 2010 Nov;113(5):1054-60. doi: 10.1097/ALN.0b013e3181f4182a. |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine 25 | Neostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3 |
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| Neostigmine 40 | Neostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3 |
|
| Neostigmine 55 | Neostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3 |
|
| Neostigmine 70 | Neostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3 |
|
| Placebo | Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3 |
|
|
|
| Neostigmine | Drug | At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70) Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow. |
|
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| Saline 0.9% | Drug | At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%. |
|
|
Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure. |
| the general anesthesia and recovery time 2 hours at least |
| 26787792 | Background | Kaufhold N, Schaller SJ, Stauble CG, Baumuller E, Ulm K, Blobner M, Fink H. Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)dagger, Br J Anaesth. 2016 Feb;116(2):233-40. doi: 10.1093/bja/aev437. |
| 34435439 | Derived | He J, He H, Li X, Sun M, Lai Z, Xu B. Required dose of sugammadex or neostigmine for reversal of vecuronium-induced shallow residual neuromuscular block at a train-of-four ratio of 0.3. Clin Transl Sci. 2022 Jan;15(1):234-243. doi: 10.1111/cts.13143. Epub 2021 Nov 2. |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |