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

NCT07580768 | Completed

• 1 other identifier: 36264MS734/11/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Dexmedetomidine; Midazolam; Propofol; Double-J Ureteral Stent

Outcome Measures

Primary Outcomes (1)

• Total propofol consumption

  Total propofol consumption was recorded.

  Intraoperatively

Secondary Outcomes (4)

• Sedation level

  30 minutes in the recovery area

• Degree of patient satisfaction

  24 hours postoperatively

• Duration of stay in the recovery area

  30 minutes in the recovery area

• Incidence of complications

  24 hours postoperatively

Study Arms (3)

Group P (Propofol alone)

ACTIVE COMPARATOR

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

Group D (Propofol and Dexmedetomidine)

EXPERIMENTAL

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

Group M (Propofol and Midazolam)

EXPERIMENTAL

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

Interventions

Propofol DRUG

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.

Group P (Propofol alone)

Propofol and Dexmedetomidine DRUG

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.

Group D (Propofol and Dexmedetomidine)

Propofol and Midazolam DRUG

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.

Group M (Propofol and Midazolam)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Propofol; Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)