Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

NCT ID: NCT05993390

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2025-08-30

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.

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.

Conditions

Neuromuscular Blockade; Critical Illness; Neurologic Findings

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sugammadex group

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.

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Intravenous administration of sugammadex 2mg/kg.

Neostigmine group

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.

Group Type: EXPERIMENTAL

Neostigmine

Intervention Type: DRUG

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sugammadex

Intravenous administration of sugammadex 2mg/kg.

Intervention Type: DRUG

Neostigmine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ho Geol Ryu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ho Geol Ryu, M.D., Ph.D

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Leerang Lim, MD

Role: CONTACT

erange@snu.ac.kr

+82-10-5063-1742

Facility Contacts

Hogeol Ryu, MD, PhD

Role: primary

hogeol@gmail.com

+82220722469 ext. 82-2-2072-2469

Leerang Lim, MD

Role: backup

erange@snu.ac.kr

+82-2072-2469 ext. 82-2-2072-1683

Other Identifiers

H-2306-197-1445

Identifier Type: -

Identifier Source: org_study_id