Effect of Neuromuscular Reversal Agents on Time for Neurological Assessment After Endotracheal Intubation in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 19 years of age or older who were intubated after admission to the intensive care unit.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sugammadex (Drug)
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.
干预措施: Neostigmine (Drug)
结局指标
主要结局
Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
时间窗: Time from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.
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.
次要结局
- 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.)
- In-ICU mortality(Date of death from any cause in ICU, up to 1 month)
- In-hospital mortality(Date of death from any cause in hospital, up to 1 month)
- 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)
- Total length of intensive care unit(ICU) stay(Date of discharge from the ICU, up to 1 month)
- Time from intubation to extubation(Date of the patient extubated, up to 1 month)
- 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)
- Total length of hospital stay(Date of discharge from the hospital, up to 1 month)
研究者
Ho Geol Ryu
Professor
Seoul National University Hospital