The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
10 juillet 2026 mis à jour par: Wei Mei, Huazhong University of Science and Technology
Ciprofol is a novel intravenous anesthetic with a pharmacological profile similar to propofol but with a lower incidence of injection pain, hypotension, and respiratory depression.
For pediatric day-case surgeries, laryngeal mask airway (LMA) insertion without neuromuscular blockers is increasingly preferred.
While opioids are often combined with hypnotics to optimize insertion conditions, the optimal bolus dose of ciprofol when co-administered with a standard dose of fentanyl for LMA insertion in children remains unknown.
This study aims to determine the 95% effective dose (ED95) of a single intravenous bolus of ciprofol, combined with a fixed dose of fentanyl (1 μg/kg), for successful LMA insertion in children aged 1-12 years during general anesthesia induction.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Description détaillée
This is a prospective, single-blind (participant and outcomes assessor-blinded), biased-coin design up-and-down sequential allocation trial. A total of 180 pediatric patients (ASA I-II) scheduled for elective surgery requiring LMA insertion will be enrolled and divided into three age groups: toddlers (1-3 years), preschoolers (4-6 years), and school-age children (7-12 years), with 60 patients per group.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute. The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg. The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053. If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
The study employs a single-blind design: the anesthesiologist who administers the study drug is aware of the ciprofol dose, whereas the anesthesiologist who performs the LMA insertion and the observer who evaluates the patient's response are both blinded to the dose assignment. LMA insertion will be attempted 90 seconds after drug administration. Successful insertion is defined as the absence of jaw tightness, gross purposeful movement, coughing, gagging, or laryngospasm during LMA insertion and cuff inflation. The primary outcome is the ED95 of ciprofol for successful LMA insertion in each age group, estimated using isotonic regression with bootstrap resampling.
Type d'étude
Interventionnel
Inscription (Estimé)
180
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Li Xu
- Numéro de téléphone: +862783663173
- E-mail: li_xu717@hust.edu.cn
Lieux d'étude
-
-
Hubei
-
Wuhan, Hubei, Chine, 430030
- Recrutement
- Tongji Hospital
-
Contact:
- Li Xu
- E-mail: li_xu717@hust.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I or II
- Aged 1 to 12 years
- Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion excision, minor abdominal or urological procedures, with expected surgical duration ≤ 2 hours)
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs
- Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases
- Inability to cooperate with peripheral intravenous cannulation
- History of reactive airway disease or suspected difficult airway
- Body mass index (BMI) ≥ 30 kg/m² or ≤ 15 kg/m²
- History of sedative medication use
- Inability to understand the study protocol or participation in another clinical trial within the past 30 days
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Toddlers (1-3 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
|
Expérimental: Preschoolers (4-6 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
|
Expérimental: School-age (7-12 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
ED95 of ciprofol for LMA insertion in children
Délai: At LMA insertion, 90 seconds after drug injection
|
The ED95 of ciprofol (combined with fentanyl 1 μg/kg) for successful LMA insertion, defined as absence of movement, coughing, gagging, or laryngospasm during insertion and cuff inflation.
|
At LMA insertion, 90 seconds after drug injection
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of adverse events within 5 minutes
Délai: Within 5 minutes after drug injection
|
Within 5 minutes after drug injection
|
|
|
mean arterial pressure (MAP)
Délai: from before induction to 1 minute afte LMA insertion
|
blood pressure were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
|
from before induction to 1 minute afte LMA insertion
|
|
heart rate
Délai: from before induction to 1 minute afte LMA insertion
|
T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
|
from before induction to 1 minute afte LMA insertion
|
|
Bispectral Index (BIS)
Délai: From before induction to 1 minute afte LMA insertion
|
BIS values were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
|
From before induction to 1 minute afte LMA insertion
|
|
Pediatric Anesthesia Emergence Delirium (PAED) scale score
Délai: Within 15-30 minutes in PACU
|
Within 15-30 minutes in PACU
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2026
Achèvement primaire (Estimé)
2 juillet 2028
Achèvement de l'étude (Estimé)
1 décembre 2028
Dates d'inscription aux études
Première soumission
2 juillet 2026
Première soumission répondant aux critères de contrôle qualité
10 juillet 2026
Première publication (Réel)
13 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TJ-IRB202606058
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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