Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 of 186 for:    GLYCOPYRROLATE

The Use of Sugammadex in the Critically Ill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03791801
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Roupen Hatzakorzian, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

Condition or disease Intervention/treatment Phase
Critical Illness Drug: Sugammadex Drug: Neostigmine Drug: Rocuronium Drug: Glycopyrrolate Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2021


Arm Intervention/treatment
Active Comparator: Neostigmine
Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
Drug: Neostigmine
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
Other Name: Prostigmin

Drug: Rocuronium
Both groups will receive rocuronium for paralysis during intubation
Other Name: Zemuron

Drug: Glycopyrrolate
The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate
Other Name: Robinul

Active Comparator: Sugammadex
Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
Drug: Sugammadex
the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
Other Name: Bridion

Drug: Rocuronium
Both groups will receive rocuronium for paralysis during intubation
Other Name: Zemuron




Primary Outcome Measures :
  1. Train of four ratio >0.9 [ Time Frame: up to 12 weeks ]
    time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791801


Contacts
Layout table for location contacts
Contact: Roupen Hatzakorzian, MD MSc 514 934 1934 ext 31104 roupenhatz@hotmail.com

Locations
Layout table for location information
Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Roupen Hatzakorzian, MD, MSc    514 934 1934 ext 34880    roupenhatz@hotmail.com   
Principal Investigator: Roupen Hatzakorzian, MD, MSc         
MUHC Recruiting
Montréal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
Layout table for investigator information
Principal Investigator: Roupen Hatzakorzian, MD MSc McGill University Health Centre/Research Institute of the McGill University Health Centre

Layout table for additonal information
Responsible Party: Roupen Hatzakorzian, MD, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03791801     History of Changes
Other Study ID Numbers: 2019-4576
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roupen Hatzakorzian, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre:
sugammadex
rocuronium
critically ill
Additional relevant MeSH terms:
Layout table for MeSH terms
Glycopyrrolate
Critical Illness
Disease Attributes
Pathologic Processes
Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists