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Intubating ConditionsNCT07680400

Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

A study testing reduced pharmacologic exposure and conventional anesthetic induction in people with Intubating Conditions, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 1 year to 10 years
Conditions the study is for
Intubating Conditions
What is being tested?
reduced pharmacologic exposure and conventional anesthetic induction
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2026to 29 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dragos Hospital

    Istanbul, Maltepe, 34844

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
reduced pharmacologic exposure, conventional anesthetic induction
Keywords
intubating conditions, dental surgery, pediatric anesthesia, opioid free anesthesia, neuromuscular blocker free anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reduced pharmacologic exposureDrug

    Also called propofol+sevoflurane

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

  • conventional anesthetic inductionDrug

    Also called sevoflurane+propofol+fentanyl+rocuronium

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

Study groups in NCT07680400
Study groupRoleWhat they receive
Group R (research group)Experimentalpediatric patients in this group will be achieve sevoflurane inhalational+propofol intravenous anesthesia induction for nasotracheal intubation
Receives: Drug: reduced pharmacologic exposure
group C (conventional group)Active comparatorpediatric patients in this group will be achieve sevoflurane inhalational+propofol+fentanyl+rocuronium intravenous anesthesia induction for nasotracheal intubation
Receives: Drug: conventional anesthetic induction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intubating conditions

    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.

    Measured: during direct laryngoscopy

Secondary outcomes (7)
  1. Hemodynamic changes during intubation

    Mean arterial pressure (mmHg)

    Measured: T1- before induction T2 - immediately after induction

  2. postoperative side effects

    laryngospasm (yes/no)

    Measured: immediately after extubation

  3. Hemodynamic changes during intubation

    Systolic Blood Pressure (mmHg)

    Measured: T1-before induction T2-immediately after induction

  4. Hemodynamic changes during intubation

    Diastolic blood pressure (mmHg)

    Measured: T1-before induction T2-immediately after induction

  5. Hemodynamic changes during intubation

    Heart rate (/min)

    Measured: T1-before induction T2-immediately after induction

  6. postoperative side effects

    desaturation (SpO2<90%)

    Measured: immeiately after extubation

  7. postoperative side effects

    sustained cough (yes/no)

    Measured: immediately after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start10 Jul 2026
  3. Primary completion29 Jul 2026
  4. Study completion29 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680400
Sponsor's protocol ID
Nkangarli003
Status last verified
Jul 2026
First submitted
14 Jun 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing reduced pharmacologic exposure and conventional anesthetic induction in people with Intubating Conditions, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intubating conditions (time frame: during direct laryngoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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