Sedation With Dexmedetomidine or Midazolam in Combination With Propofol for Removal of Double-J Ureteral Stent
5. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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El-Gharbia
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Tanta, El-Gharbia, Egypt, 31527
- Tanta University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
|
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.
|
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Eksperimentell: 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
|
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.
|
|
Eksperimentell: 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.
|
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total propofol consumption
Tidsramme: Intraoperatively
|
Total propofol consumption was recorded.
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Intraoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sedation level
Tidsramme: 30 minutes in the recovery area
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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)
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30 minutes in the recovery area
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Degree of patient satisfaction
Tidsramme: 24 hours postoperatively
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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
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24 hours postoperatively
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Duration of stay in the recovery area
Tidsramme: 30 minutes in the recovery area
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Duration of stay in the recovery area was recorded.
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30 minutes in the recovery area
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Incidence of complications
Tidsramme: 24 hours postoperatively
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Incidence of complications such as apnea, laryngospasm, hypotension, bradycardia, nausea, vomiting, or any other complication were recorded.
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24 hours postoperatively
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2024
Primær fullføring (Faktiske)
1. oktober 2025
Studiet fullført (Faktiske)
1. oktober 2025
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Azoler
- Hydrokarboner
- Hydrokarboner, syklisk
- Hydrokarboner, aromatisk
- Imidazoles
- Fenoler
- Benzenderivater
- Benzazepiner
- Benzodiazepiner
- Midazolam
- Dexmedetomidin
- Propofol
Andre studie-ID-numre
- 36264MS734/11/24
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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