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Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring
At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neostigmine | Active Comparator | At the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg |
|
| Sugammadex | Active Comparator | At the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of postoperative residual curarization | definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9 | Immediately after entering PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AhYoung Oh, M.D Ph. D | Department of anesthesiology and pain medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31977627 | Derived | Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2022 | |
| Reset | Feb 9, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2022 | Feb 9, 2023 |
| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sugammadex | Drug | Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal |
|
|
| D009861 |
| Onium Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |