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Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

160

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • elective dental surgery ASA 1-3 Age 1-10

Exclusion Criteria:

  • anticipated difficult intubation
  • vocal cord pathology or disease
  • hoarssness

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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
Andere Namen:
  • propofol+sevoflurane
Aktiver Komparator: 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
Andere Namen:
  • sevoflurane+propofol+fentanyl+rocuronium

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
intubating conditions
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemodynamic changes during intubation
Zeitfenster: T1- before induction T2 - immediately after induction
Mean arterial pressure (mmHg)
T1- before induction T2 - immediately after induction
postoperative side effects
Zeitfenster: immediately after extubation
laryngospasm (yes/no)
immediately after extubation
Hemodynamic changes during intubation
Zeitfenster: T1-before induction T2-immediately after induction
Systolic Blood Pressure (mmHg)
T1-before induction T2-immediately after induction
Hemodynamic changes during intubation
Zeitfenster: T1-before induction T2-immediately after induction
Diastolic blood pressure (mmHg)
T1-before induction T2-immediately after induction
Hemodynamic changes during intubation
Zeitfenster: T1-before induction T2-immediately after induction
Heart rate (/min)
T1-before induction T2-immediately after induction
postoperative side effects
Zeitfenster: immeiately after extubation
desaturation (SpO2<90%)
immeiately after extubation
postoperative side effects
Zeitfenster: immediately after extubation
sustained cough (yes/no)
immediately after extubation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

14. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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