ACTRN12623001329651招募中未知
derstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study-3: a randomised, double-blind cross-over trial in healthy volunteers undergoing sedation with dexmedetomidine
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •Adults, ages greater than or equal to 18 and 40 years old
- •In good health, determined by the PI on the basis of medical history and a standard assessment for anaesthesia to be documented as part of the study record
- •English Language Proficiency (suitable to provide informed consent and participate in research activities).
排除标准
- •Adults <18 years old or >40 years old
- •Pregnancy confirmed on pregnancy test on day of sedation
- •Use of recreational drugs
- •Use of sedatives/sleeping medication within 24 hours prior to sedation visit
- •Prescription for opioids (chronic or PRN) or other medications that cause sedation
- •Contraindication to anaesthesia or allergy to study drug
- •Difficult anaesthesia: American Society of Anesthesiologists Physical Status greater than 1, per the discretion of the PI. Examples of ASA>1 status includes, but are not limited to:
- •oAny systemic disease present, such as diabetes, cardiac, pulmonary, or other acute or chronic disorder, or history of smoking
- •oNarrow angle glaucoma
- •oAbnormal airway examination
- •oAny abnormality on physical examination that could increase anaesthetic risk
- •oSnoring or sleep disorders including apnea
- •oAntecedent pulmonary aspiration risk (e.g., history GI reflux, heartburn, hiatal hernia)
- •oAdverse reaction or allergy with anaesthesia or other sedatives
- •oChronic medication use
- •oHistory of difficult anaesthesia, laryngoscopy or intubation
- •oFamily history of difficulty with anaesthesia or sedation
- •oHistory of vertigo, nausea or vomiting after anaesthesia
- •Contraindication to HD-EEG for relative parts of the procedures.
- •Exclusion from Dexmedetomidine:
- •oResting heart Rate<50 bpm
- •oKnown dexmedetomidine allergy
- •People working in anaesthesia (such as anaesthetic registrars)
- •People who are occupationally exposed to the study drugs.
- •Additional exclusion criteria on the day of sedation:
- •Anything to eat or drink for the preceding 6 hours (excluding clear fluids)
- •Anything to drink for the preceding 2 hours
- •Any use of over-the-counter or recreational drugs (including alcohol or tobacco) within the preceding 24 hours
- •Any use of opioid, sedative or sleep agents within the preceding 24 hours
- •Recent change in health, including cough, cold, or fever
- •Exposure to anaesthesia or sedation in the last 6 days
研究者
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