Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study
The Methodist Hospital Research Institute
Summary
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: 1. randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery 2. fill out a questionnaire day 1 and day 2 after surgery 3. fill out a medication diary for one week after surgery 4. visit the clinic on day 2 after surgery for checkup 5. visit the clinic on day 4-7 after surgery for check up
Description
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18-70 years old 2. Patients who are undergoing unilateral retrograde ureteroscopy (semi-rigid or flexible) with planned ureteral stent placement for treatment of renal/ureteral stones 3. Patients who can read and understand English 4. Patients who can follow up post-operatively within 7 days at Houston Methodist Hospital Exclusion Criteria: 1. Untreated UTI 2. HbA1c ≥6.5 on preoperative testing 3. Patients with prior diagnosis of any type of diabetes mellitus 4. Patients with immunosuppression, including chronic corticosteroid use 5. Patients with bleeding disorde…
Interventions
- DrugDexamethasone Sodium Phosphate Injection 20 mg
dexamethasone 20 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia
- DrugDexamethasone Sodium Phosphate Injection 4mg
dexamethasone 4 mg diluted in 50 mL of normal saline administered by intravenous drip after induction of anesthesia
Location
- Houston Methodist HospitalHouston, Texas