Recruiting

Sugammadex

Sponsor:

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

Code:

NCT03791801

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sugammadex

Neostigmine

Rocuronium

Glycopyrrolate

Study Details

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

Conditions

Critical Illness

Study ID

NCT03791801

Start date

Sep 1, 2019

Status verified date

Aug, 2019

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Dec 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Neostigmine

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

active comparator: Sugammadex

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

Interventions

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

Primary outcome measure

  • Train of four ratio >0.9 [ Time Frame: up to 12 weeks ]

Central Contacts and Locations

Central contacts

Roupen Hatzakorzian, MD MSc

514 934 1934roupenhatz@hotmail.com

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Roupen Hatzakorzian, MD, MSc

514 934 1934roupenhatz@hotmail.com

Principal Investigator:

Roupen Hatzakorzian, MD, MSc

MUHC

Recruiting

Montréal, Quebec, Canada, H4A 3J1

More Information

Sponsor

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

Last update posted

Aug 21, 2019

Last verified

Aug, 2019

Keywords

  • sugammadex
  • rocuronium
  • critically ill

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-08-21.