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Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

11. maj 2026 opdateret af: Siyament cangir, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial

This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.

Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.

In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.

Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.

Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.

Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.

This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Pediatric patients aged 2-10 years
  • ASA physical status I-II
  • Scheduled for elective inguinal or urological surgery under general anesthesia
  • Both male and female patients
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

  • Known allergy or hypersensitivity to dexmedetomidine or midazolam
  • Presence of significant systemic disease or organ dysfunction
  • Cardiac arrhythmia or congenital heart disease
  • Neurological or behavioral disorders, including developmental delay
  • Chronic use of analgesics or other medications that may affect study outcomes
  • Anticipated difficult airway
  • Nasal pathology that may interfere with intranasal drug administration
  • Emergency surgery
  • Inability to obtain written informed consent from parents or legal guardians

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: Midazolam Group
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding. This approach ensures consistent administration routes across study groups.
Medicin: Midazolam
Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Andre navne:
  • Dormicum
Eksperimentel: Dexmedetomidine Group
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
Medicin: Dexmedetomidine
Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
Andre navne:
  • Precedex

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients achieving adequate sedation at anesthesia induction
Tidsramme: Approximately 30 minutes after premedication, at anesthesia induction
Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
Approximately 30 minutes after premedication, at anesthesia induction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parent-child separation anxiety score
Tidsramme: At parent-child separation before anesthesia induction

Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of >2 is defined as significant separation anxiety.

Unit of Measure: Units on a scale
At parent-child separation before anesthesia induction
Mask acceptance at induction
Tidsramme: At the time of mask application during anesthesia induction
Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction. Mask Acceptance will be defined as WDS 1-2.
At the time of mask application during anesthesia induction
Postoperative emergence agitation
Tidsramme: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Emergence agitation will be assessed using the Watcha Behavior Scale (WDS). Agitation will be defined as WDS >2.
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Need for rescue sedation
Tidsramme: From premedication until anesthesia induction
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
From premedication until anesthesia induction
PACU recovery time
Tidsramme: During PACU stay until discharge criteria are met
Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
During PACU stay until discharge criteria are met
Postoperative pain score
Tidsramme: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Postoperative pain will be assessed using the FLACC scale.
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Extubation time
Tidsramme: Intraoperative to immediate postoperative period
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
Intraoperative to immediate postoperative period
Mean Arterial Pressure (MAP)
Tidsramme: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).

Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period.

Unit of Measure: mmHg
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
Heart Rate (HR)
Tidsramme: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).

Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia.

Unit of Measure: Beats per minute (bpm)
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
Oxygen Saturation (SpO2)
Tidsramme: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).

SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status.

Unit of Measure: Percentage (%)
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).

Samarbejdspartnere og efterforskere

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

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Efterforskere

  • Studieleder: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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)

5. maj 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

26. september 2026

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 27/01/2026-35

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

IPD-delingstidsramme

Starting 6 months and ending 36 months following article publication.

IPD-delingsadgangskriterier

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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