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The Use of Sugammadex in the Critically Ill

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03791801
Enrollment
50
Registered
2019-01-03
Start date
2019-09-01
Completion date
2021-07-01
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

sugammadex, rocuronium, critically ill

Brief 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

Interventions

DRUGSugammadex

the reversal of neuromuscular blockade with sugammadex compared to neostigmine.

DRUGNeostigmine

the reversal of neuromuscular blockade with sugammadex compared to neostigmine.

DRUGRocuronium

Both groups will receive rocuronium for paralysis during intubation

DRUGGlycopyrrolate

The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Train of four ratio >0.9up to 12 weekstime from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio \>0.9

Countries

Canada

Contacts

Primary ContactRoupen Hatzakorzian, MD MSc
roupenhatz@hotmail.com514 934 1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026