ISRCTN43755713已完成不适用
Remifentanil versus fentanyl for analgesia-based sedation to provide patient comfort in the intensive care unit
GlaxoSmithKline (UK)0 个研究点目标入组 152 人开始时间: 2003年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Admitted into the ICU within the previous 24 hours
- •2. Intubated and expected to require short-term mechanical ventilation (i.e. for at least a further 12 hours and up to 72 hours after starting the study drug infusion)
- •3. Aged over 18 years old
- •4. A female is eligible to enter and participate in this study if she is of:
- •4.1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or,
- •4.2. Child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
- •4.2.1. Complete abstinence from intercourse from two weeks prior to administration of study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (minimum of 7 days)
- •4.2.2. Female sterilisation
- •4.2.3. Sterilisation of male partner
- •4.2.4. Implants of levonorgestrel
- •4.2.5. Injectable progestogen
- •4.2.6. Oral contraceptive (combined or progestogen only)
- •4.2.7. Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion)
- •4.2.8. Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year
- •4.2.9. Barrier method only if used in combination with one of the above methods
- •5. Weighs an estimated 120 kg or less
- •6. Informed consent: a signed and dated written informed consent or assent must be obtained from the subject or the subject's legally acceptable representative, respectively, prior to study participation
- •7. Language: fluent and literate in the language spoken by the investigator and staff
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Concurrent medications:
- •1.1. Requires neuromuscular blocking agents to facilitate mechanical ventilation
- •1.2. Has or is likely to receive an epidural block during the maintenance phase
- •2. The use of remifentanil, fentanyl or propofol is contraindicated
- •3. Concurrent disease or disorder:
- •3.1. Has or is likely to require a tracheostomy within 96 hours after admission to the ICU
- •3.2. Has a neurological disease or other medical condition that may affect the ability to assess the SAS score and PI (e.g. stroke, stupor or coma, dementia)
- •3.3. Predicted creatinine clearance of <50 mL/min indicating moderate or severe renal impairment
- •3.4. Modified ICU admission simplified acute physiology score (SAPS) II score of greater than 43
- •4. Drug allergy: history of allergic hypersensitivity to fentanyl analogues, morphine, benzodiazepines or propofol
- •5. History of alcohol abuse
- •6. History of drug abuse: clinically significant abuse of opioid or sedative containing substances, defined as:
- •6.1. Patterns of substance intake consistent with disruption of normal function in society
- •6.2. Past or current impairment of organ function reasonably related to substance intake
- •7. Previous entry into this study or participation in any other investigational drug study within 30 days of randomisation
- •8. Concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device
- •9. Protocol specified treatment regimens would be inappropriate for the management of the subject
- •10. The subject will have been in the ICU for longer than 24 hours at the time of starting the study drug infusion
研究者
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