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Neuromuscular BlockadeNCT05993390

Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

A study testing Sugammadex and Neostigmine in people with Neuromuscular Blockade and Critical Illness, run by Seoul National University Hospital at 1 site in South Korea.

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Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 19 to 90 years
What is being tested?
Sugammadex and Neostigmine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
11 Jan 2024to 30 Apr 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients 19 years of age or older who were intubated after admission to the intensive care unit.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leerang Lim, MD contact

+82-10-5063-1742

erange@snu.ac.kr

South Korea1 site, 1 recruiting
  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

    Hogeol Ryu, MD, PhD, +82220722469 ext. 82-2-2072-2469, hogeol@gmail.com

    Leerang Lim, MD, +82-2072-2469 ext. 82-2-2072-1683, erange@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

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

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:

Read more
  • 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.

Read the detailed description

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.
Being tested
Sugammadex, Neostigmine
Keywords
Reversal of neuromuscular blockade, Neurologic assessment, Endotracheal intubation, Critically ill patient
Medical subject headings
Critical Illness, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SugammadexDrug

    Intravenous administration of sugammadex 2mg/kg.

  • NeostigmineDrug

    Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg

Study groups in NCT05993390
Study groupRoleWhat they receive
Sugammadex groupExperimentalPatient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered sugammadex 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of sugammadex. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.
Receives: Drug: Sugammadex
Neostigmine groupExperimentalPatient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered neostigmine 0.05mg/kg + glycopyrrolate 0.01mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of neostigmine. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.
Receives: Drug: Neostigmine
Control groupNo interventionPatient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 60 minutes after intubation. After 60 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (8)
  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.

    Measured: 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

    Measured: Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes

  3. Changes of regional cerebral oxygen saturation (O3) values

    Changes of regional cerebral oxygen saturation (O3) values

    Measured: Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes

  4. Time from intubation to extubation

    Time from intubation to extubation, up to 1 month

    Measured: Date of the patient extubated, up to 1 month

  5. Total length of hospital stay

    Total length of hospital stay, up to 1 month

    Measured: Date of discharge from the hospital, up to 1 month

  6. Total length of intensive care unit(ICU) stay

    Total length of intensive care unit(ICU) stay, up to 1 month

    Measured: Date of discharge from the ICU, up to 1 month

  7. In-ICU mortality

    In-ICU mortality, up to 1 month

    Measured: Date of death from any cause in ICU, up to 1 month

  8. In-hospital mortality

    In-hospital mortality, up to 1 month

    Measured: Date of death from any cause in hospital, up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start11 Jan 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993390
Sponsor's protocol ID
H-2306-197-1445
Status last verified
May 2026
First submitted
19 Jul 2023
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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