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.
Patients who agree to participate in the study will be randomized to the sugammadex group, neostigmine group, or control group. Randomization will be performed by an independent investigator. Patient, medical staff performing patient evaluation are masked for the assignment otherwise the medical staff administering medications to patient is not blinded. An independent investigator, who is not included in this study, will provide the assignment result to the medical staff administering medications to patient. 1. Neurologic assessment The point at which first available neurologic assessment is defined as the point at which the patient is able to move on command (Motor score of 6 on the GCS), and the GCS will be assessed until that point. Regardless of randomization outcome, all patients will be monitored for GCS and monitored for processed EEG and cerebral regional oxygen saturation prior to intubation. Assessment of GCS before administration of sedatives for endotracheal intubation, every 10 minutes after intubation, before administration of study medications, every 5 minutes until 30 minutes after administration of study medications, and every 10 minutes after 30 minutes, with additional assessments at that time if spontaneous eye opening occurs. The GCS will be assessed until directed movement is possible (Motor score of 6 on the GCS). Eye opening response: If there is no response after 2 repetitions of 'OOO, please open your eyes', the response is evaluated with 2 repetitions of the stimulus of pressing the thumb nail. If the subject opens his/her eyes spontaneously, skip this assessment. Motor response: 'Please make a fist' and 'Please open your fist' are performed twice, and if there is no response, the stimulus of pressing the thumb nail is performed twice to assess the response. 2. Processed EEG and cerebral regional oxygen saturation Processed EEG using Masimo's Next Generation SedLine® Brain Function Monitoring, and cerebral regional oxygen saturation using Masimo's O3® Regional Oximetry is monitored and recorded. Processed EEG and cerebral regional oxygen saturation will be recorded at 10 minute intervals from before sedation for intubation until neurological function can be assessed. 3. Neuromuscular function monitoring Utilized by the Philips Intellivue NMT(neuromuscular transmission) monitor. Monitor every 5 minutes beginning 30 minutes after Rocuronium dosing and discontinue monitoring if eyes open spontaneously (Eye score of 4 on GCS). 4. Endotracheal intubation 100% oxygen is delivered via a facial fitting mask. Patients who have been maintained on oxygen via a high-flow nasal cannula are given 100% oxygen with a flow rate of 60 L/min. Sedation is administered with etomidate 0.1-0.2 mg/kg, and endotracheal intubation is performed with rocuronium 1 mg/kg once the patient's loss of consciousness is confirmed. 5. Drug Administration Sugammadex treatment group Neuromuscular function monitoring is performed every 5 minutes starting 30 minutes after rocuronium administration. Sugammadex 0.2 mg/kg 30 minutes after rocuronium is administered, after GCS assessment and neuromuscular function monitoring. Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex administration is recorded. Neostigmine group Neuromuscular function monitoring is performed every 5 minutes starting 30 minutes after rocuronium administration. Administer neostigmine 0.05 mg/kg + glycopyrrolate 0.01 mg/kg after rocuronium is administered, after GCS assessment and neuromuscular function monitoring. Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex administration is recorded. Control group Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex administration is recorded. 6. GCS assessment and neuromuscular function monitoring is performed 30 minutes after rocuronium administration, and processed EEG and cerebral regional oxygen saturation levels is recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Intravenous administration of sugammadex 2mg/kg.
Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
RECRUITINGTime 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.
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.
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 minutes
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 minutes
Time from intubation to extubation
Time from intubation to extubation, up to 1 month
Time frame: Date of the patient extubated, up to 1 month
Total length of hospital stay
Total length of hospital stay, up to 1 month
Time frame: Date of discharge from the hospital, up to 1 month
Total length of intensive care unit(ICU) stay
Total length of intensive care unit(ICU) stay, up to 1 month
Time frame: Date of discharge from the ICU, up to 1 month
In-ICU mortality
In-ICU mortality, up to 1 month
Time frame: Date of death from any cause in ICU, up to 1 month
In-hospital mortality
In-hospital mortality, up to 1 month
Time frame: Date of death from any cause in hospital, up to 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.