Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993390
• Other study ID #: H-2306-197-1445
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: September 2023
• Source: Seoul National University Hospital
• Contact: Leerang Lim, MD
• Phone: +82-10-5063-1742
• Email: erange[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 30, 2025
• Est. primary completion date: August 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Neurologic Manifestations
• Neuromuscular Blockade

Intervention

Drug:
• Sugammadex
Intravenous administration of sugammadex 2mg/kg.
• Neostigmine
Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.
Secondary	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 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.
Secondary	Changes of Patient State index (PSi) values	Changes of Patient State index (PSi) values	Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes
Secondary	Changes of regional cerebral oxygen saturation (O3) values	Changes of regional cerebral oxygen saturation (O3) values	Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes
Secondary	Time from intubation to extubation	Time from intubation to extubation, up to 1 month	Date of the patient extubated, up to 1 month
Secondary	Total length of hospital stay	Total length of hospital stay, up to 1 month	Date of discharge from the hospital, up to 1 month
Secondary	Total length of intensive care unit(ICU) stay	Total length of intensive care unit(ICU) stay, up to 1 month	Date of discharge from the ICU, up to 1 month
Secondary	In-ICU mortality	In-ICU mortality, up to 1 month	Date of death from any cause in ICU, up to 1 month
Secondary	In-hospital mortality	In-hospital mortality, up to 1 month	Date of death from any cause in hospital, up to 1 month