Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients

NCT05993390 | Recruiting DMC

• 1 other identifier: H-2306-197-1445
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade; Critical Illness; Neurologic Findings

Keywords

Reversal of neuromuscular blockade; Neurologic assessment; Endotracheal intubation; Critically ill patient

Outcome Measures

Primary Outcomes (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.

  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)

• 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, in minutes), assessed up to 48 hours.

• 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

• 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

• Time from intubation to extubation

  Date of the patient extubated, up to 1 month

• Total length of hospital stay

  Date of discharge from the hospital, up to 1 month

Study Arms (3)

Sugammadex group

EXPERIMENTAL

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.

Drug: Sugammadex

Neostigmine group

EXPERIMENTAL

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.

Drug: Neostigmine

Control group

NO INTERVENTION

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.

Interventions

Sugammadex DRUG

Intravenous administration of sugammadex 2mg/kg.

Sugammadex group

Neostigmine DRUG

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

Neostigmine group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Critical Illness; Neurologic Manifestations

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Ho Geol Ryu, M.D., Ph.D

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Leerang Lim, MD

CONTACT

+82-10-5063-1742; erange@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 15, 2023
• Study Start: January 11, 2024
• Primary Completion: August 14, 2025
• Study Completion: August 30, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)