Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubating Conditions
• Intervention / Treatment: Drug: reduced pharmacologic exposure; Drug: conventional anesthetic induction

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group R (research group); pediatric patients in this group will be achieve sevoflurane inhalational+propofol intravenous anesthesia induction for nasotracheal intubation	Drug: reduced pharmacologic exposure; patients in group R will undergo combination of sevoflurane and propofol only anesthesia induction; Other Names: propofol+sevoflurane
Active Comparator: group C (conventional group); pediatric patients in this group will be achieve sevoflurane inhalational+propofol+fentanyl+rocuronium intravenous anesthesia induction for nasotracheal intubation	Drug: conventional anesthetic induction; in group C, conventional anesthetic regimen will be used for anesthesia induction; Other Names: sevoflurane+propofol+fentanyl+rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during direct laryngoscopy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: dental surgery; pediatric anesthesia; opioid free anesthesia; intubating conditions; neuromuscular blocker free anesthesia
• Other Study ID Numbers: Nkangarli003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No