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

5. maj 2026 opdateret af: Reem Adel Hafiz, Tanta University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.
Eksperimentel: 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
Medicin: 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.
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total propofol consumption
Tidsramme: Intraoperatively
Total propofol consumption was recorded.
Intraoperatively

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2024

Primær færdiggørelse (Faktiske)

1. oktober 2025

Studieafslutning (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 36264MS734/11/24

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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Kliniske forsøg med Sedation

Kliniske forsøg med Propofol

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Betingelser

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