Sedation, Dexmedetomidine, Midazolam, Propofol, Double-J Ureteral Stent
Conditions
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.
Interventions
Patients received dexmedetomidine 1 µg/kg intravenous titrated with 10 ml of normal saline injected within 10 min prior to propofol administration by 10 min. Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
DRUGPropofol and Midazolam
Patients received midazolam 0.05 mg/kg titrated with 10 ml of normal saline injected intravenous within 10 min prior to propofol administration by 10 min. Propofol was injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
DRUGPropofol
Patients received 10 ml of normal saline injected intravenous within 10 min then intravenous propofol titrated with normal saline and injected with a dose of 1.5 mg/kg for the first bolus dose followed by intermittent doses of 20 mg per dose according to patient's needs.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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/m2. * History of allergy to one of the drugs used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total propofol consumption | Intraoperatively | Total propofol consumption was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation level | 30 minutes in the recovery area | Sedation level was assessed preoperatively, every 5 minutes during the procedure and every 10 min during stay in the recovery area by Ramsay sedation scale classified 1-6 (1= anxious, 2= calm,3= lethargic, 4= confused and responsive to auditory stimuli, 5= sluggish response to auditory stimuli, 6= No response to painful stimuli) |
| Degree of patient satisfaction | 24 hours postoperatively | Degree of patient satisfaction was assessed by using a 5 point Likert scale as follows 1. extremely dissatisfied; 2. unsatisfied; 3. neutral; 4. satisfied; 5. extremely satisfied |
| Duration of stay in the recovery area | 30 minutes in the recovery area | Duration of stay in the recovery area was recorded. |
| Incidence of complications | 24 hours postoperatively | Incidence of complications such as apnea, laryngospasm, hypotension, bradycardia, nausea, vomiting, or any other complication were recorded. |
Countries
Egypt
Outcome results
None listed