- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07680400
Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.
25. června 2026 aktualizováno: Nıgar Kangarlı, Bezmialem Vakif University
Nasotracheal Intubating Conditions With Reduced Pharmacologic Exposure After Propofol-sevoflurane Induction in Pediatric Parients: a Randomized Contolled Trial
Pediatric anesthesia differs significantly from adult anesthesia due to physiological differences and increased sensitivity to anesthetic agents.
In surgeries requiring nasotracheal intubation, such as dental and maxillofacial procedures, achieving optimal intubation conditions while minimizing pharmacological exposure is of considerable importance.
The combination of propofol and sevoflurane is frequently preferred in pediatric anesthesia because it provides rapid induction and stable hemodynamic conditions.
Therefore, this randomized controlled trial aims to evaluate nasotracheal intubation conditions following propofol-sevoflurane induction with reduced pharmacological exposure in pediatric patients.
The study is expected to contribute to clinical practice by enhancing patient safety while reducing anesthetic drug use.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
This study is planned as a prospective, randomized, controlled single blind trial.
Pediatric patients aged 2-10 years, classified as ASA physical status I-III and scheduled for elective dental surgery requiring nasotracheal intubation, will be enrolled after written informed consent has been obtained from their parents or legal guardians.
Exclusion criteria include patients with anticipated difficult intubation, disease of vocal cords, hoarseness or any vocal cord pathology.
To ensure standardization, all patients will receive oral midazolam 0,5 mg/kg (mixed in 10 mL of fruit juice) as premedication 30 minutes before surgery.
Upon arrival in the operating room, standard monitoring including non-invasive blood pressure, electrocardiography, and peripheral oxygen saturation monitoring will be established.
Baseline systolic, diastolic, and mean arterial blood pressures, as well as heart rate, will be recorded prior to induction (T0).
In addition, bispectral index (BIS) monitoring and train-of-four (TOF) monitoring will be used to assess anesthetic depth and neuromuscular blockade respectively.
Patients will be randomly allocated in two groups by opaque sealed envelope technique.
The group, to be anesthesized by conventional method (sevoflurane+propofol+fentanyl+rocuronium), group C, the control group, while, the research group, or group R, will be treated with reduced pharmacologic approach (sevoflurane+propofol).
All patients will receive inhalational anesthetic induction with 8% sevoflurane in 100% oxygen at a flow rate of 10 L/min via face mask.
Sevoflurane concentration will be maintained at 1.5-2.0
minimum alveolar concentration (MAC), and spontaneous ventilation will be supplied by manual bag ventilation in concordance with patients' spontanenous effort, under continuos monitorization of end-tidal CO2.
The vaporizer dial will be manipulated in order to keep MAC at 1.5-2.0 and BİS at 40-50.
After intravenous access is established, patients in group C will receive fentanyl 1 μg/kg, propofol 2.5 mg/kg, and rocuronium 0.3 mg/kg intravenously.
Patients in group R will receive 2.5 mg /kg propofol only.
Sevoflurane will be switched off after intravenous induction in both groups.
Both groups will achieve 10mg/kg paracetamol as preemptive analgesia as soon as intravenous access is established.Time, from initiation to discontinuation of sevoflurane will be recorded separately.
Hemodynamic parameters, TOF and BIS values will be recorded just after induction (T1).
Nasotracheal intubation with appropriate endotracheal tube (ETT) size will be performed by anesthesiologist with at least 2 years experience in pediatric nasotracheal intubation and minimum 500 pediartic intubations performed.
In group C, endotracheal tube will be placed in the nostril after acceptable fade of TOF and BIS values between 40-50.
İn group R, placement of endotracheal tube will coincide with total loss of spontaneous breathing, eyelash reflex, purposeful movements and BIS of 40-50.
At the time of laryngoscope placement, another anesthesia practitioner, who is blinded to the group allocated, will be invited to evaluate the intubating conditions under direct laryngoscopy.
The intubating score will be established according to GCRP guidelines and categorized as "excellent," "good," or "poor."
'Excellent' and 'good' intubating conditions will be rated as accepatble.
If 'poor' circumstances are encountered in any of groups, rescue treatment with additional dose of rocuronium and deepening anestesia will be applied.
Time, required from initiation to termination and confirmation of correctly placed ETT and number of attempts will be also recorded.
Any airway reactions following inflation of the endotracheal tube cuff will be documented separately.
Hemodynamic parameters will be recorded immediately after intubation and cuff inflation (T2).
Maintenance of anesthesia will be conducted by sevoflurane at MAC 1.0 and oxygen 40% gas mixture at 1 lpm in all patients.
Ventilation parameters will be as follows: tidal volume of 7 mL/kg, age-appropriate respiratory rate and PEEP of 5 cmH₂O in volume-controlled mode.
All patients will be injected with 4% articaine with 1:100,000 epinephrine solution for local anesthesia prior to initiation of surgery.
At the end of surgery, surgical duration and total sevoflurane consumption will be recorded.
Upon extubation, group C will be administered weight-based doses of atropine and neostigmine after adequate TOF (>0.9)and
BIS (>60) values.
In group R, extubation will be performed once adequate BIS and TOF values along with effective spontaneous ventilation will be achieved (confirmed by adequate chest excursion and tidal volume generation by the patient).
During extubation and until transfer to the postoperative recovery unit, straining, gagging, respiratory distress (SpO₂ <90%), laryngospasm, and any other airway-related adverse events will be assessed and recorded.
In the postoperative recovery area, nausea and vomiting, pain (assessed using the FLACC score), and emergence agitation/delirium (assessed using the PAED score) will be evaluated and documented.
Typ studie
Intervenční
Zápis (Odhadovaný)
160
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- elective dental surgery ASA 1-3 Age 1-10
Exclusion Criteria:
- anticipated difficult intubation
- vocal cord pathology or disease
- hoarssness
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Group R (research group)
pediatric patients in this group will be achieve sevoflurane inhalational+propofol intravenous anesthesia induction for nasotracheal intubation
|
patients in group R will undergo combination of sevoflurane and propofol only anesthesia induction
Ostatní jména:
|
|
Aktivní komparátor: group C (conventional group)
pediatric patients in this group will be achieve sevoflurane inhalational+propofol+fentanyl+rocuronium intravenous anesthesia induction for nasotracheal intubation
|
in group C, conventional anesthetic regimen will be used for anesthesia induction
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
intubating conditions
Časové okno: during direct laryngoscopy
|
the intubating score, based on GCRP guidelines, provides 3 levels of intubating conditions: poor, good and excellent.
'good' and 'excellent' conditions are considered as acceptable and are studied for two groups.
|
during direct laryngoscopy
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hemodynamic changes during intubation
Časové okno: T1- before induction T2 - immediately after induction
|
Mean arterial pressure (mmHg)
|
T1- before induction T2 - immediately after induction
|
|
postoperative side effects
Časové okno: immediately after extubation
|
laryngospasm (yes/no)
|
immediately after extubation
|
|
Hemodynamic changes during intubation
Časové okno: T1-before induction T2-immediately after induction
|
Systolic Blood Pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Časové okno: T1-before induction T2-immediately after induction
|
Diastolic blood pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Časové okno: T1-before induction T2-immediately after induction
|
Heart rate (/min)
|
T1-before induction T2-immediately after induction
|
|
postoperative side effects
Časové okno: immeiately after extubation
|
desaturation (SpO2<90%)
|
immeiately after extubation
|
|
postoperative side effects
Časové okno: immediately after extubation
|
sustained cough (yes/no)
|
immediately after extubation
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
1. srpna 2026
Dokončení studie (Odhadovaný)
1. srpna 2026
Termíny zápisu do studia
První předloženo
14. června 2026
První předloženo, které splnilo kritéria kontroly kvality
25. června 2026
První zveřejněno (Aktuální)
2. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Nkangarli003
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Podmínky intubace
-
Cairo UniversityDokončenoFekry VS Air-Q Intubating AirwaysEgypt