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The Use of Sugammadex in the Critically Ill

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Rocuronium
Glycopyrrolate
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring sugammadex, rocuronium, critically ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University Health CenterRecruiting
  • MUHCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neostigmine

Sugammadex

Arm Description

Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1

Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2018
Last Updated
August 19, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03791801
Brief Title
The Use of Sugammadex in the Critically Ill
Official Title
Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
sugammadex, rocuronium, critically ill

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
Prostigmin
Intervention Description
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Zemuron
Intervention Description
Both groups will receive rocuronium for paralysis during intubation
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Other Intervention Name(s)
Robinul
Intervention Description
The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate
Primary Outcome Measure Information:
Title
Train of four ratio >0.9
Description
time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roupen Hatzakorzian, MD MSc
Phone
514 934 1934
Ext
31104
Email
roupenhatz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roupen Hatzakorzian, MD MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roupen Hatzakorzian, MD, MSc
Phone
514 934 1934
Ext
34880
Email
roupenhatz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Roupen Hatzakorzian, MD, MSc
Facility Name
MUHC
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Sugammadex in the Critically Ill

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