Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent

Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent: A Randomized Double-Blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Sedation; Dexmedetomidine; Propofol; Midazolam; Double-J Ureteral Stent
• Intervention / Treatment: Drug: Propofol; Drug: Propofol and Dexmedetomidine; Drug: Propofol and Midazolam

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group P (Propofol alone); 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.	Drug: Propofol; 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.
Experimental: Group D (Propofol and Dexmedetomidine); 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	Drug: Propofol and Dexmedetomidine; 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.
Experimental: Group M (Propofol 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.	Drug: Propofol 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total propofol consumption	Total propofol consumption was recorded.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation level	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)	30 minutes in the recovery area
Degree of patient satisfaction	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	24 hours postoperatively
Duration of stay in the recovery area	Duration of stay in the recovery area was recorded.	30 minutes in the recovery area
Incidence of complications	Incidence of complications such as apnea, laryngospasm, hypotension, bradycardia, nausea, vomiting, or any other complication were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine; Propofol
• Other Study ID Numbers: 36264MS734/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No