- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07680400
Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.
29 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
160
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Maltepe
-
Istanbul, Maltepe, Turquia (Türkiye), 34844
- Dragos Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- elective dental surgery ASA 1-3 Age 1-10
Exclusion Criteria:
- anticipated difficult intubation
- vocal cord pathology or disease
- hoarssness
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
Outros nomes:
|
|
Comparador Ativo: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
intubating conditions
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemodynamic changes during intubation
Prazo: T1- before induction T2 - immediately after induction
|
Mean arterial pressure (mmHg)
|
T1- before induction T2 - immediately after induction
|
|
postoperative side effects
Prazo: immediately after extubation
|
laryngospasm (yes/no)
|
immediately after extubation
|
|
Hemodynamic changes during intubation
Prazo: T1-before induction T2-immediately after induction
|
Systolic Blood Pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Prazo: T1-before induction T2-immediately after induction
|
Diastolic blood pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Prazo: T1-before induction T2-immediately after induction
|
Heart rate (/min)
|
T1-before induction T2-immediately after induction
|
|
postoperative side effects
Prazo: immeiately after extubation
|
desaturation (SpO2<90%)
|
immeiately after extubation
|
|
postoperative side effects
Prazo: immediately after extubation
|
sustained cough (yes/no)
|
immediately after extubation
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de julho de 2026
Conclusão Primária (Real)
29 de julho de 2026
Conclusão do estudo (Real)
29 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
14 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de junho de 2026
Primeira postagem (Real)
2 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Nkangarli003
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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