Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children
5. mai 2026 oppdatert av: Rui Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children: A Prospective, Up-and-Down Sequential Allocation Study
This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
Laryngeal mask airway (LMA) insertion is a common practice in pediatric day surgery.
While it is less invasive than endotracheal intubation, children exhibit high airway reactivity, requiring an optimal depth of anesthesia to suppress airway reflexes.
Alfentanil is an opioid with a rapid onset and short duration of action, making it potentially ideal for LMA insertion.
However, current dosage recommendations for alfentanil are often extrapolated from tracheal intubation studies, which may lead to overdosage, respiratory depression, or delayed recovery in children.
This study aims to determine the precise effective dose (ED50 and ED95) of alfentanil when combined with a fixed dose of propofol for smooth LMA insertion in children.
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Rui Zhang, M.D.
- Telefonnummer: +86 15802025520
- E-post: zhangr52@mail.sysu.edu.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University
-
Ta kontakt med:
- Tairan Lin, M.D.
- Telefonnummer: +86 15622130745
- E-post: talonlam@foxmail.com
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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
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged 7 to 12 years
- Undergoing elective day surgery
- ASA physical status I-II
- Body Mass Index (BMI) between 14 and 24 kg/m²
- Accompanied by a fully capable guardian within 24 hours after discharge
Exclusion Criteria:
- Allergy to opioids
- Unresolved upper respiratory tract infection within the past 1 week
- Abnormal heart, lung, liver, or kidney function, or metabolic diseases
- Airway anatomical abnormalities (e.g., micrognathia, laryngomalacia, macroglossia) or OSAHS (Obstructive Sleep Apnea-Hypopnea Syndrome)
- Use of analgesics, sedatives, or other psychotropic drugs within the past 2 weeks
- Refusal to sign the informed consent form
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Alfentanil Sequential Dose Group
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All patients receive 2.5 mg/kg propofol injected over 30 seconds.
Alfentanil is administered 1 minute prior to propofol.
The dose is adjusted by steps of 2 µg/kg based on the previous patient's response (successful insertion = decrease dose; failed insertion = increase dose).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Success of LMA insertion
Tidsramme: Intraoperative (During LMA insertion procedure)
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Assessed by the absence of body movement, coughing, breath-holding, severe hemodynamic changes, or insertion difficulty.
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Intraoperative (During LMA insertion procedure)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time required for LMA insertion
Tidsramme: Intraoperative (from LMA pick-up to successful placement).
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The time (in seconds) from picking up the LMA to the first successful breath as confirmed by capnography.
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Intraoperative (from LMA pick-up to successful placement).
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Number of LMA insertion attempts
Tidsramme: Intraoperative (during the anesthesia induction phase).
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The total number of attempts required to successfully place the LMA.
An attempt is defined as the introduction of the LMA into the patient's mouth.
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Intraoperative (during the anesthesia induction phase).
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Airway Responses
Tidsramme: During and up to 1 minute post-insertion
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Incidence and severity of body movement, cough, breath-holding, and laryngospasm.
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During and up to 1 minute post-insertion
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Changes in Heart Rate (HR)
Tidsramme: From baseline (pre-induction) up to 1 minute after LMA insertion.
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Evaluation of heart rate (beats per minute) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
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From baseline (pre-induction) up to 1 minute after LMA insertion.
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Changes in Mean Arterial Pressure (MAP)
Tidsramme: From baseline (pre-induction) up to 1 minute after LMA insertion.
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Evaluation of mean arterial pressure (mmHg) to assess hemodynamic stability at four time points: T0 (baseline), T1 (post-induction), T2 (immediate post-insertion), and T3 (1 min post-insertion).
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From baseline (pre-induction) up to 1 minute after LMA insertion.
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Awakening time
Tidsramme: From end of surgery up to 1 hour.
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The interval from the discontinuation of anesthetic agents to the moment the patient follows simple commands or opens eyes.
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From end of surgery up to 1 hour.
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Post-Anesthesia Care Unit (PACU) discharge time
Tidsramme: Up to PACU discharge(assessed up to 4 hours after surgery completion).
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The duration (in minutes) from arrival in the PACU until the patient meets discharge criteria.
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Up to PACU discharge(assessed up to 4 hours after surgery completion).
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Postoperative Adverse Events
Tidsramme: At 6 hours and 24 hours post-operation
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Incidence of PONV (postoperative nausea and vomiting), sore throat, and hoarseness.
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At 6 hours and 24 hours post-operation
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
30. august 2026
Studiet fullført (Antatt)
30. mars 2027
Datoer for studieregistrering
Først innsendt
22. april 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
Andre studie-ID-numre
- IIT2026026
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