Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ)
研究概览
简要总结
The purpose of this study to learn if high-dose dexamethasone, a type of long-acting steroid, works to decrease urinary symptoms and pain after ureteroscopy and stent placement for kidney stones. The main question it aims to answer is:
1) Does high-dose steroid change the quality of life score on day 2 after surgery
Researchers will compare high-dose of dexamethasone (20 mg) to a standard dose of dexamethasone (4 mg) to see if a higher dose of the drug will help with urinary symptoms and pain
Participants will:
- randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery
- fill out a questionnaire day 1 and day 2 after surgery
- fill out a medication diary for one week after surgery
- visit the clinic on day 2 after surgery for checkup
- visit the clinic on day 4-7 after surgery for check up
详细描述
Patient will be in the study for a duration of 30 days. Randomization will be performed on the day of surgery using the NIH Clinical Trial Randomization Tool.
In the preoperative area, a finger stick blood glucose (FSBG) level will be checked. Patients with a FSBG ≥126 mg/dL will be disqualified from the study.
Following induction of general anesthesia, the anesthesiologist will administer the study drug (dexamethasone 20 mg vs 4 mg) without members of the surgery team in the operating room. This is the only treatment that will be done for research purpose. The following are part of routine clinical care. Perioperative antibiotic prophylaxis will be given by the discretion of the surgeon following Houston Methodist Hospital (HMH) and American Urological Association (AUA) guidelines. Ureteroscopy (URS) will then be performed. If laser lithotripsy will be performed, a holmium or thulium laser will be used. After URS is completed, a ureteral stent will be placed. The length of the stent will be determined by the patient's height. Stent string can be left on or removed prior to placement based on surgeon discretion. Subjects will be prescribed tamsulosin (0.4 mg, #30), docusate (100 mg, #60), extended-release oxybutynin (10 mg, #30), and tramadol (50 mg, #20) OR acetaminophen/codeine (325/30 mg, #20). Stent removal will be performed in clinic 4-7 days after surgery.
FSBG will be checked upon patient's arrival to the PACU. Postop corrective insulin lispro LOW dose will be administered if needed and FSBG will be rechecked in one hour according to Houston Methodist's "Diabetes and Hyperglycemia Management Postop" protocol.
Persistent hyperglycemia will be defined as FSBG ≥200 one hour after insulin administration. If patient is experiencing persistent hyperglycemia, they will be admitted for monitoring. An endocrinologist will be consulted for evaluation and treatment of hyperglycemia and its acute complication if suspected.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Patients who are undergoing unilateral retrograde ureteroscopy (semi-rigid or flexible) with planned ureteral stent placement for treatment of renal/ureteral stones
- •Patients who can read and understand English
- •Patients who can follow up post-operatively within 7 days at Houston Methodist Hospital
排除标准
- •Untreated UTI
- •HbA1c ≥6.5 on preoperative testing
- •Patients with prior diagnosis of any type of diabetes mellitus
- •Patients with immunosuppression, including chronic corticosteroid use
- •Patients with bleeding disorder
- •Patients with chronic liver disease, cirrhosis, and liver failure.
- •Patients taking strong CYP3A4 inducers or inhibitors within two weeks of screening
- •Chronic opioid analgesic use
- •Congenital renal abnormalities (e.g. pelvic kidney, ureteric duplication) that may impair stent placement
- •Concurrent genitourinary malignancy
- •Urinary diversion
- •Renal transplantation
- •History of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (e.g. endometriosis)
- •Neurologic disorder (e.g. spinal cord injury, multiple sclerosis, spina bifida)
- •Pregnant or breastfeeding
- •Patients with cognitive impairments or untreated psychiatric illness
研究组 & 干预措施
Treatment Arm
Dexamethasone 20 mg
干预措施: Dexamethasone Sodium Phosphate Injection 20 mg (Drug)
Control Arm
Dexamethasone 4 mg
干预措施: Dexamethasone Sodium Phosphate Injection 4mg (Drug)
结局指标
主要结局
Global Quality of Life Score of Ureteral Stent Symptom Questionnaire (USSQ)
时间窗: Day 2 after surgery
A 1 to 7 rating scale used to measure survey participants' feeling if they were advised to have another stent inserted, from 1 = delighted to 7 = terrible.
次要结局
- Urinary Index Score of the USSQ(Day 2 after surgery)
- Pain Index Score of the USSQ(Day 2 after surgery)
- General Health Index Score of the USSQ(Day 2 after surgery)
- Work Performance Index Score of the USSQ(Day 2 after surgery)
- Opioid Use After Surgery(From intervention to stent removal at 4-7 days after surgery)
研究者
Monica Morgan
Assistant Professor of Clinical Urology
The Methodist Hospital Research Institute