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Completed

NCT Number: NCT07680400

Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

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.

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dragos Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

reduced pharmacologic exposure

Drug

patients in group R will undergo combination of sevoflurane and propofol only anesthesia induction

Other names: propofol+sevoflurane

conventional anesthetic induction

Drug

in group C, conventional anesthetic regimen will be used for anesthesia induction

Other names: sevoflurane+propofol+fentanyl+rocuronium

Primary outcomes

  1. intubating conditions

    Time frame: 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.

Secondary outcomes

  1. Hemodynamic changes during intubation

    Time frame: T1- before induction T2 - immediately after induction

    Mean arterial pressure (mmHg)

  2. postoperative side effects

    Time frame: immediately after extubation

    laryngospasm (yes/no)

  3. Hemodynamic changes during intubation

    Time frame: T1-before induction T2-immediately after induction

    Systolic Blood Pressure (mmHg)

  4. Hemodynamic changes during intubation

    Time frame: T1-before induction T2-immediately after induction

    Diastolic blood pressure (mmHg)

  5. Hemodynamic changes during intubation

    Time frame: T1-before induction T2-immediately after induction

    Heart rate (/min)

  6. postoperative side effects

    Time frame: immeiately after extubation

    desaturation (SpO2<90%)

  7. postoperative side effects

    Time frame: immediately after extubation

    sustained cough (yes/no)

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Nasotracheal Intubating Conditions With Reduced Pharmacologic Exposure After Propofol-sevoflurane Induction in Pediatric Parients: a Randomized Contolled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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