A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients

Study Overview
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Brief Summary
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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.)

Official Title
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A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients.

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex Reversal
* Drug: Atropine/Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 4 AND ASA 4E patients Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. - Exclusion Criteria: Patients ASA 1-3 or 5 Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.). Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR). Hypersensitivity to the active substances or to any of the excipients of medications used Patients with severe renal impairment (including patients requiring dialysis (CrCl < 30mL/min)) Patients with severe hepatic impairment Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex (tradename Bridion)<br> | Drug: Sugammadex Reversal<br> <br> |
| Active Comparator: Traditional reversal or spontaneous recovery:<br>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. | Drug: Atropine/Neostigmine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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.) |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in ASA 4 AND ASA 4E patients