Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Siyament Cangir, M.D.
- Telefonnummer: +905534411047
- E-post: siyamentcangir@gmail.com
Studer Kontakt Backup
- Navn: Fatma K Acil, M.D.
- Telefonnummer: +905337225225
- E-post: acilfatma@gmail.com
Studiesteder
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Outside of the US
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Diyarbakır, Outside of the US, Tyrkia (Türkiye), 21070
- Rekruttering
- Siyament Cangir
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Ta kontakt med:
- Fatma Acil, M.D.
- Telefonnummer: +905337225225
- E-post: acilfatma@gmail.com
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Ta kontakt med:
- Siyament Cangir, M.D.
- Telefonnummer: +905534411047
- E-post: siyamentcangir@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
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
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: 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.
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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 navn:
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Eksperimentell: 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.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Proportion of patients achieving adequate sedation at anesthesia induction
Tidsramme: Approximately 30 minutes after premedication, at anesthesia induction
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Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
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Approximately 30 minutes after premedication, at anesthesia induction
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Parent-child separation anxiety score
Tidsramme: At parent-child separation before anesthesia induction
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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
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Mask acceptance at induction
Tidsramme: At the time of mask application during anesthesia induction
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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.
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At the time of mask application during anesthesia induction
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Postoperative emergence agitation
Tidsramme: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Emergence agitation will be assessed using the Watcha Behavior Scale (WDS).
Agitation will be defined as WDS >2.
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At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Need for rescue sedation
Tidsramme: From premedication until anesthesia induction
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Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
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From premedication until anesthesia induction
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PACU recovery time
Tidsramme: During PACU stay until discharge criteria are met
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Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
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During PACU stay until discharge criteria are met
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Postoperative pain score
Tidsramme: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Postoperative pain will be assessed using the FLACC scale.
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At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
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Extubation time
Tidsramme: Intraoperative to immediate postoperative period
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Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
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Intraoperative to immediate postoperative period
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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).
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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).
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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).
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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).
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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).
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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).
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Forvirring
- Nevroatferdsmanifestasjoner
- Nevrokognitive lidelser
- Delirium
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Emergence Delirium
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Azoler
- Imidazoles
- Benzazepiner
- Benzodiazepiner
- Midazolam
- Dexmedetomidin
Andre studie-ID-numre
- 27/01/2026-35
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
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