Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent: A Randomized Double-Blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
The aim of this study is to compare the efficacy of intravenous sedation using propofol alone or in combination with dexmedetomidine or midazolam for the removal of double J (D-J) ureteral stent.
Detailed Description
Ureteral double J (D-J) stents have been common practice in the management of various urological conditions. D-J stents are often employed to alleviate pain, prevent infection, and clear obstructions encountered during urological treatments.
Dexmedetomidine is a selective α2-adrenergic receptor agonist ( α2- AR), offering both sedation and pain relief while preserving respiratory function. Despite these benefits, one of the potential drawbacks of this medication is its tendency to lower both heart rate and blood pressure as a result of its sympatholytic properties.
Midazolam, a drug belonging to the benzodiazepines class, is commonly used for premedication before anesthesia, procedural sedation, and managing intense agitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 21 to 65 years.
- •Both sex.
- •Physical status of the patients were from I-III according to American Society of Anesthesiologists (ASA).
- •Patients underwent Double-J ureteral stent removal.
Exclusion Criteria
- •Symptoms of lower urinary tract infection.
- •Stenosis of the urethra during cystoscopy.
- •Renal impairment (serum creatinine >1.5 mg/dL).
- •Chronic pain syndrome.
- •Mental disorder and difficulty in communication.
- •History of chronic use of sedatives, alcohol and narcotics.
- •Bradycardia (heart rate less than 50 beats per minute).
- •Systolic blood pressure less than 90 mm Hg.
- •Taking a sedative or analgesic 24 hours before surgery.
- •Body mass index (BMI) equal or over 35 kg/m
- •History of allergy to one of the drugs used in the study.
Investigators
Reem Adel Hafiz
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.
Tanta University