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Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

Primary Purpose

Neuromuscular Blockade, Critical Illness, Neurologic Findings

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Blockade focused on measuring Reversal of neuromuscular blockade, Neurologic assessment, Endotracheal intubation, Critically ill patient

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Sugammadex group

    Neostigmine group

    Control group

    Arm Description

    Patient 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.

    Patient 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.

    Patient 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Changes of Patient State index (PSi) values
    Changes of Patient State index (PSi) values
    Changes of regional cerebral oxygen saturation (O3) values
    Changes of regional cerebral oxygen saturation (O3) values
    Time from intubation to extubation
    Time from intubation to extubation, up to 1 month
    Total length of hospital stay
    Total length of hospital stay, up to 1 month
    Total length of intensive care unit(ICU) stay
    Total length of intensive care unit(ICU) stay, up to 1 month
    In-ICU mortality
    In-ICU mortality, up to 1 month
    In-hospital mortality
    In-hospital mortality, up to 1 month

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05993390
    Brief Title
    Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients
    Official Title
    Effect of Neuromuscular Reversal Agents on Time for Neurological Assessment After Endotracheal Intubation in Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 11, 2023 (Anticipated)
    Primary Completion Date
    August 14, 2025 (Anticipated)
    Study Completion Date
    August 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.
    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. 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. 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. 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). 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. 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. GCS assessment and neuromuscular function monitoring is performed 30 minutes after rocuronium administration, and processed EEG and cerebral regional oxygen saturation levels is recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuromuscular Blockade, Critical Illness, Neurologic Findings
    Keywords
    Reversal of neuromuscular blockade, Neurologic assessment, Endotracheal intubation, Critically ill patient

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sugammadex group
    Arm Type
    Experimental
    Arm Description
    Patient 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.
    Arm Title
    Neostigmine group
    Arm Type
    Experimental
    Arm Description
    Patient 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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patient 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sugammadex
    Intervention Description
    Intravenous administration of sugammadex 2mg/kg.
    Intervention Type
    Drug
    Intervention Name(s)
    Neostigmine
    Intervention Description
    Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg
    Primary Outcome Measure Information:
    Title
    Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
    Description
    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 Outcome Measure Information:
    Title
    Time from administration of neuromuscular blocker to first available spontaneous eye opening (in minutes)
    Description
    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.
    Title
    Changes of Patient State index (PSi) values
    Description
    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
    Title
    Changes of regional cerebral oxygen saturation (O3) values
    Description
    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
    Title
    Time from intubation to extubation
    Description
    Time from intubation to extubation, up to 1 month
    Time Frame
    Date of the patient extubated, up to 1 month
    Title
    Total length of hospital stay
    Description
    Total length of hospital stay, up to 1 month
    Time Frame
    Date of discharge from the hospital, up to 1 month
    Title
    Total length of intensive care unit(ICU) stay
    Description
    Total length of intensive care unit(ICU) stay, up to 1 month
    Time Frame
    Date of discharge from the ICU, up to 1 month
    Title
    In-ICU mortality
    Description
    In-ICU mortality, up to 1 month
    Time Frame
    Date of death from any cause in ICU, up to 1 month
    Title
    In-hospital mortality
    Description
    In-hospital mortality, up to 1 month
    Time Frame
    Date of death from any cause in hospital, up to 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leerang Lim, MD
    Phone
    +82-10-5063-1742
    Email
    erange@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ho Geol Ryu, M.D., Ph.D
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

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