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To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 & 4E patients
Primary endpoint:
• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.
Secondary endpoints:
• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex (tradename Bridion) | Experimental |
| |
| Traditional reversal or spontaneous recovery: | Active Comparator | Atropine/Neostigmine: Atropine, 0.02 mg/ kg, and Neostigmine,0.05 mg/kg diluted in 100 ml Normal Saline and given over a 10 min drip. Reversal will be given only recommended if spontaneous recovery has occurred up to the reappearance of T2 (shallow blockade) following rocuronium induced blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Reversal | Drug |
| ||
| Atropine/Neostigmine |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to extubation - measure the difference in time from application of the surgical dressing until extubation. | 24 hours | |
| Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.) |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of Sugammadex on cortisol levels | 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Lemberg, PhD | Contact | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Yoram G Weiss, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Recruiting | Jerusalem | 91120 | Israel |
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| Drug |
|
| 24 hours |
| ID | Term |
|---|---|
| D001285 | Atropine |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009861 | Onium Compounds |
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