Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- incidence of hypotension
研究概览
简要总结
A prospective, double-blinded, multicenter randomized control trial. All critically ill patients above 12 years of age requiring continuous sedation for >24hrs in the ICU will be screened and those meeting selection criteria (and consented) will be enrolled into the study.
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详细描述
165 participants shall be consecutively randomized into either sedation with ketamine-midazolam or morphine-midazolam group using a block sequence technique; group concealed in brown envelopes. Blinding will be at patient/next of kin level as well as investigator/data collector level.
Enrolled subjects shall be followed up for treatment history, co-morbidities and related data will be collected, results analyzed and study findings will be availed to ICU physicians and Ministry of health to guide treatment considerations and for health care planning.
Data shall be collected using a standardized questionnaire by trained research assistants. It will be double entered into Epidata and exported to STATA version 12.0 for analysis. Continuous variables will be expressed as means and standard deviations, while categorical data will be expressed as frequencies with their respective percentages. Linear regression and logistic regression used to analyse primary outcomes, as well as multivariate analysis to detect associations.
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
- Double (Participant, Investigator)
盲法说明
Drugs will be premixed and coded for ketamine-midazolam or morphine-midazolam. The colorless drug mixture shall be provided to the attending physician to start the infusion at 2ml/hour and to be titrated to the desired level of sedation.
The investigator and participant will be unaware of which group a certain patient is under.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >12years of age.
- •Anticipated need for sedation for >24hours.
排除标准
- •Hypertensive crisis i.e. sustained SBP >200mmHg/DBP>110mmHg
- •Status epilepticus
- •Ischemic heart disease and severe LV dysfunction
- •Persistent tachyarrythmias
- •History of mental illness
- •Hypersensitivity to ketamine, morphine or midazolam.
- •Tetanus -due to the muscle rigidity that may be caused by ketamine. Reasons for exclusions 1 to 4; Ketamine stimulates the sympathetic nervous system causing transient increase in myocardial work and blood pressure and has psychoactive effects
结局指标
主要结局
incidence of hypotension
时间窗: 14 days
incidence of hypotension requiring vasopressor support.
duration of mechanical ventilation
时间窗: 14 days
in hours from start of mechanical ventialtion
incidence of delirium
时间窗: 14 days
assessed daily with the CAM-ICU score
次要结局
- ICU length of stay(14 days)
- mortality rate(within 14 days)