The Use of Sugammadex in the Critically Ill
Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial
1 other identifier
interventional
50
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedAugust 21, 2019
August 1, 2019
1.3 years
December 18, 2018
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Neostigmine
ACTIVE COMPARATORWill receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
Sugammadex
ACTIVE COMPARATORWill receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
Interventions
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
Both groups will receive rocuronium for paralysis during intubation
The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate
Eligibility Criteria
You may qualify if:
- Adult patients requiring intubation in the intensive care unit
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
McGill University Health Center
Montreal, Quebec, H3A 1A1, Canada
MUHC
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roupen Hatzakorzian, MD MSc
McGill University Health Centre/Research Institute of the McGill University Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 18, 2018
First Posted
January 3, 2019
Study Start
September 1, 2019
Primary Completion
December 1, 2020
Study Completion
July 1, 2021
Last Updated
August 21, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share