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Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Active Comparator | Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. |
|
| Neostigmine/atropine | Active Comparator | Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug |
|
| |
| Neostigmine/atropine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Mini-Mental State Evaluation test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) | |
| Change in the clock-drawing test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) | |
| Change in the Isaacs set test | Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from reversal agent administration to extubation | After reversal agent administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str. | Athens | 12462 | Greece |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
|
| 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 |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |