- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07680400
Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.
29 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
160
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maltepe
-
Istanbul, Maltepe, Turkiet (Türkiye), 34844
- Dragos Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- elective dental surgery ASA 1-3 Age 1-10
Exclusion Criteria:
- anticipated difficult intubation
- vocal cord pathology or disease
- hoarssness
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Aktiv 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
intubating conditions
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hemodynamic changes during intubation
Tidsram: T1- before induction T2 - immediately after induction
|
Mean arterial pressure (mmHg)
|
T1- before induction T2 - immediately after induction
|
|
postoperative side effects
Tidsram: immediately after extubation
|
laryngospasm (yes/no)
|
immediately after extubation
|
|
Hemodynamic changes during intubation
Tidsram: T1-before induction T2-immediately after induction
|
Systolic Blood Pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Tidsram: T1-before induction T2-immediately after induction
|
Diastolic blood pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Tidsram: T1-before induction T2-immediately after induction
|
Heart rate (/min)
|
T1-before induction T2-immediately after induction
|
|
postoperative side effects
Tidsram: immeiately after extubation
|
desaturation (SpO2<90%)
|
immeiately after extubation
|
|
postoperative side effects
Tidsram: immediately after extubation
|
sustained cough (yes/no)
|
immediately after extubation
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 juli 2026
Primärt slutförande (Faktisk)
29 juli 2026
Avslutad studie (Faktisk)
29 juli 2026
Studieregistreringsdatum
Först inskickad
14 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Nkangarli003
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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