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In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S | Active Comparator | Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2. |
|
| Group SN1 | Active Comparator | Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. |
|
| Grup SN2 | Active Comparator | Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular monitoring | Diagnostic Test | TOF monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual curarization rate | Pecents of Patients TOFR<0.9 | through study completion an average of 3 months |
| SPO2 | peripheric oxygen saturation | through study completion an average of 3 months |
| MAP | Mean arterial pressure | through study completion an average of 3 months |
| HR | Heart Rate | through study completion an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PONV | Postoperative nausea and vomiting | through study completion an average of 3 months |
| Time to Return of bowel movements | when patients' bowel movements return |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aysun Postacı | Contact | +9005323520383 | aysunposta@yahoo.com | |
| Rıdvan Durgut | Contact | +90 05532316058 | ridvandurgut35rd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aysun Postacı | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39287249 | Derived | Postaci A, Durgut R, Aytac BG, Ceyhan M. Effect of sugammadex with neostigmine on postoperative bowel function and on recovery of neuromuscular functions: A randomized controlled trial. Medicine (Baltimore). 2024 Sep 13;103(37):e39623. doi: 10.1097/MD.0000000000039623. |
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Prospective randomized controlled double blind study
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| reverse of NMB with sugammadex | Other | Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2. |
|
| reverse of NMB with Sugammadex and neostigmin low dose | Other | Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg |
|
| reverse of NMB with Sugammadex and neostigmin high dose | Other | patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg |
|
| through study completion an average of 3 months |
| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| D020250 | Postoperative Nausea and Vomiting |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D061886 | Neuromuscular Monitoring |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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