The Use of Sugammadex in the Critically Ill

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791801
• Other study ID #: 2019-4576
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2019
• Source: McGill University Health Center
• Contact: Roupen Hatzakorzian, MD MSc
• Phone: 514 934 1934
• Email: roupenhatz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Sugammadex
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
• Neostigmine
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
• Rocuronium
Both groups will receive rocuronium for paralysis during intubation
• Glycopyrrolate
The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
Canada	MUHC	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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