Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
研究概览
简要总结
The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.
详细描述
Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
Data collected will include:
I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom & Problem Index ii. Revised McGill Pain Score
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
- •Gender of Patients: Male & female,Age of Patients: 18 and older
排除标准
- •Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
干预措施: Dexmedetomidine (Drug)
Normal Saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
时间窗: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average
It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.
次要结局
未报告次要终点
研究者
Suzanne Karan
Principal investigator
University of Rochester