Clinical trial

Effect of Neuromuscular Reversal Agents on Time for Neurological Assessment After Endotracheal Intubation in Critically Ill Patients

Name
H-2306-197-1445
Description
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.
Trial arms
Trial start
2023-09-11
Estimated PCD
2025-08-14
Trial end
2025-08-30
Status
Not yet recruiting
Treatment
Sugammadex
Intravenous administration of sugammadex 2mg/kg.
Arms:
Sugammadex group
Neostigmine
Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg
Arms:
Neostigmine group
Size
30
Primary endpoint
Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
Time from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.
Eligibility criteria
Inclusion Criteria: * Adult patients 19 years of age or older who were intubated after admission to the intensive care unit. Exclusion Criteria: * 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 * Patients taking or planning to take toremifene, fusidic acid, or hormonal contraceptives
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-09-06

1 organization

2 products

3 indications

Product
Sugammadex