The Use of Sugammadex in the Critically Ill

Study Overview
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Brief Summary
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Moderate and Deep neuromuscular blockade (rocuronium administered to a train of four count 0 and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in an already weakened population

Detailed Description
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The Critically ill is a special population needing immediate and aggressive treatments and interventions. Neuromuscular blockade is frequently used to secure an airway, optimize ventilation/oxygenation in ARDS, aid in maintaining hypothermia in patients post-cardiac arrest. Muscle relaxants can also contribute to neuromuscular weakness in the critically ill which can be a devastating condition. Appropriate depth of neuromuscular blockade is important but unnecessary paralysis need to be avoided. Rocuronium is one of the most popular neuromuscular blockade agents used in the critically ill (1). Sugammadex is a modified γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular blocking agents rocuronium and vecuronium (2). Sugammadex results in rapid, predictable recovery from moderate and deep neuromuscular blockade. Sugammadex has been mostly studied and used in the surgical population but its use outside the operating room is still very relevant. The investigators set up to evaluate the potential benefit that may result from the reversal of NMB with sugammadex compared to neostigmine. Objectives In critically ill patients undergoing intubation receiving appropriate depth of NMB (moderate and deep blockade) the investigators will assess: Primary objective: 1. To determine if choice of reversal agent affects time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9 Secondary objectives: To document the ability of 1.0 mg/kg rocuronium (maximum 100 mg) to achieve satisfactory intubation conditions in the ICU, based on measurement of the number of intubation attempts and intubation grades in the entire cohort To document General adverse effects: Hemodynamic instability, need for vasopressors etc

Official Title
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Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Rocuronium
* Drug: Glycopyrrolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients requiring intubation in the intensive care unit Exclusion Criteria: Patients younger than 18 yr, to have known or suspected neuromuscular disease, allergies to medications to be used during intubation, a (family) history of malignant hyperthermia or severe renal insufficiency (glomerular filtration rate <30 ml/h) will not be eligible.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine<br>Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1 | Drug: Neostigmine<br>* the reversal of neuromuscular blockade with sugammadex compared to neostigmine.<br>* Other names: Prostigmin;Drug: Rocuronium<br>* Both groups will receive rocuronium for paralysis during intubation<br>* Other names: Zemuron;Drug: Glycopyrrolate<br>* The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate<br>* Other names: Robinul;|
| Active Comparator: Sugammadex<br>Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure). | Drug: Sugammadex<br>* the reversal of neuromuscular blockade with sugammadex compared to neostigmine.<br>* Other names: Bridion;Drug: Rocuronium<br>* Both groups will receive rocuronium for paralysis during intubation<br>* Other names: Zemuron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Train of four ratio >0.9 | time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9 | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugammadex, rocuronium, critically ill