A DOSE RANGING STUDY TO EVALUATE THE EFFECTIVENESS OF FOSPROPOFOL (LUSEDRA®) FOR INDUCTION OF ANESTHESIA FOR OUTPATIENT UROLOGIC HYDRODILATION THERAPY
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
研究概览
简要总结
Interstitial cystitis is a condition where a defect in the protective lining of the bladder causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6 months.
Since this is a painful procedure an anesthesiologist will give you a drug that will make you unconscious for the procedure. General anesthesia can be given to you through an IV tube that is placed in a vein in your arm. There are only a few agents that induce sedation and these agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at the injection site and a prolonged time to consciousness.
This study will be comparing doses of a new IV sedation induction agent drug to put you to sleep called fospropofol (Lusedra®).
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients
- •> 18-65 years of age,
- •weight 60-90 kg,
- •with an American Society of Anesthesiologists (ASA) physical status of P1 to P3 are eligible for enrollment.
- •Female patients of child bearing age will have a negative urine pregnancy test result and have used an acceptable method of birth control for >1 month prior to study enrollment.
- •Patients will be NPO >6 hours and scheduled for outpatient urological hydrodilation under general anesthesia.
- •Patients also will not be enrolled in another study or have received an experimental drug in the prior 30 days.
- •Exclusion criteria are:
- •hypersensitivity or allergy to any anesthesia, opioids, benzodiazepines or any drugs used in the study, failure to meet NPO status or an abnormal, clinically significant ECG finding.
- •Another exclusion is the presence of a difficult airway that would prevent use of the laryngeal mask airway (LMA) or successful LMA insertion.
- •Women who are breast feeding would also be excluded from participation.
排除标准
- 未提供
研究组 & 干预措施
6.5 milligram per kilogram of Fospropofol (Lusedra®)
干预措施: Fospropofol (Lusedra®) 6.5 (Drug)
10 milligram per kilogram of Fospropofol (Lusedra®)
干预措施: Fospropofol (Lusedra®) 10 (Drug)
12 milligram per kilogram of Fospropofol (Lusedra®)
干预措施: Fospropofol (Lusedra®) 12 (Drug)
结局指标
主要结局
To evaluate the differences in dose on the time to loss of consciousness and loss of reflex using the laryngeal mask airway (LMA).
时间窗: 1 day
To evaluate the use, dosing, efficacy and safety of fospropofol (Lusedra®) for the induction of general anesthesia using the laryngeal mask airway (LMA) in outpatient urology patients receiving hydrodilation therapy.
次要结局
- To evaluate the difference in dose on blood pressure and heart rate using the laryngeal mask airway (LMA)(1 day)
研究者
Grace Shih, MD
Associate Professor
University of Kansas Medical Center