NCT03791801

The Use of Sugammadex in the Critically Ill

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. 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 2. To document General adverse effects: Hemodynamic instability, need for vasopressors etc

Conditions

• Critical Illness

Interventions

Type	Name	Description
DRUG	Sugammadex	the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
DRUG	Neostigmine	the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
DRUG	Rocuronium	Both groups will receive rocuronium for paralysis during intubation
DRUG	Glycopyrrolate	The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-12-01
• Completion: 2021-07-01
• First posted: 2019-01-03
• Last updated: 2019-08-21

Locations

2 sites across 1 country: Canada