Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Compare delirium and coma free days until 14 days after end of deep sedation
研究概览
简要总结
The goal of this clinical trial is to investigate the effectiveness of sedation guided by the bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs used in critical patients who require deep sedation. The main questions this study aims to answer are:
- Does sedation guided by BIS lead to higher delirium and coma-free days compared to clinical monitoring?
- Does sedation guided by BIS result in reduced doses of sedative drugs compared to clinical monitoring?
Participants in this study will be randomly assigned to one of two groups:
Clinical Monitoring Group: Participants in this group will receive sedation based on clinical scales. These participants will also be fitted with a BIS sensor, but the sensor will be covered.
Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the bispectral index.
The study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. The primary outcomes to be evaluated include:
- Delirium and coma-free days after the end of deep sedation using the Confusion Assessment Method for the ICU (CAM-ICU) scale.
- Total dose of sedative drugs administered.
- BIS values
Researchers will compare the two groups to determine if sedation guided by BIS is associated with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher values of BIS compared to clinical monitoring.
详细描述
A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to sedation guided by clinical scales in critically ill patients under deep sedation. The primary objective is to investigate whether BIS-guided sedation can reduce the incidence of delirium and decrease the doses of sedative drugs administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The primary outcome "Compare delirium and coma-free days until 14 days after the end of deep sedation" will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. The evaluations will be conducted by blinded evaluators who are unaware of the patient's assigned sedation management group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years.
- •Under mechanical ventilation in the intensive care unit
- •Indication of deep sedation (RASS objective -4, -5)
- •Admission to the ICU or indication of deep sedation up to 8 hours prior to randomization.
排除标准
- •Patients with end-of-life care.
- •Family refusal to participate in the study.
- •Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone position, etc.).
- •Patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves.
- •Patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.
结局指标
主要结局
Compare delirium and coma free days until 14 days after end of deep sedation
时间窗: Up to 14 days post end of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of \> -3.
Compare the doses of sedative drugs received
时间窗: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation
Compare values of BIS
时间窗: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups
次要结局
- Compare days alive and free of the ICU(From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days)
- Time with values of BIS less than 40(From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days)
- Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation(Up to 14 days post end of deep sedation)
- Compare days alive and free of the hospital(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days)
- Compare days alive and free of mechanical ventilation through Study Day 30(From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days)
- Compare days alive and free of mechanical ventilation through Study Day 60(From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days)
研究者
Ivan A Huespe, MD
Principal Investigator
Hospital Italiano de Buenos Aires