Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorSeoul National University Hospital
About this trial
The goal of this clinical trial is to compare the effect of use of reversal agents for neuromuscular blockade in critically ill patients on time for neurological assessment after endotracheal intubation
The main questions it aims to answer are:
* The use of reversal agents for neuromuscular blockade after endotracheal intubation may reduce the time for neurological assessment. * The types of reversal agents for neuromuscular blockade may affect the time for neurological assessment.
Participants will receive different reversal agents or no medications based on the assigned groups. Thirty minutes after intubation using rocuronium, medication is administered, and the time of initial confirmation of eye opening and movement is recorded.
Researchers will compare 3 groups (sugammadex, neostigmine and control(no medication) to see the difference of time for neurological assessment after endotracheal intubation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients 19 years of age or older who were intubated after admission to the intensive care unit.
Disqualifiers
Patients younger than 19 years of age
Patients who are not neurologically evaluable or have concomitant neurologic dysfunction
Patients with neuromuscular disorder
Patients with a history of drug allergic reactions to sugammadex or neostigmine
Trial design
Design model
Parallel
Treatments tested in this trial
Sugammadex
DrugIntravenous administration of sugammadex 2mg/kg.
Neostigmine
DrugIntravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Sugammadex groupExperimental treatment 1 intervention
Group B: Neostigmine groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
Time from administration of neuromuscular blocker to the first time the patient is able to make a directed movement (Motor score 6 on GCS), assessed up to 48 hours.
Time frame
Time from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.Secondary outcomes
1
Time from administration of neuromuscular blocker to first available spontaneous eye opening (in minutes)
Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS), assessed up to 48 hours.
Time frame
Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS, in minutes), assessed up to 48 hours.2
Changes of Patient State index (PSi) values
Changes of Patient State index (PSi) values
Time frame
Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes3
Changes of regional cerebral oxygen saturation (O3) values
Changes of regional cerebral oxygen saturation (O3) values
Time frame
Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes4
Time from intubation to extubation
Time from intubation to extubation, up to 1 month
Time frame
Date of the patient extubated, up to 1 monthSponsors and contacts
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Source ClinicalTrials.gov