Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

NCT07680400 | Completed

• 1 other identifier: Nkangarli003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intubating Conditions

Keywords

intubating conditions; dental surgery; pediatric anesthesia; opioid free anesthesia; neuromuscular blocker free anesthesia

Outcome Measures

Primary Outcomes (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.

  during direct laryngoscopy

Secondary Outcomes (7)

• Hemodynamic changes during intubation

  T1- before induction T2 - immediately after induction

• postoperative side effects

  immediately after extubation

• Hemodynamic changes during intubation

  T1-before induction T2-immediately after induction

• Hemodynamic changes during intubation

  T1-before induction T2-immediately after induction

• Hemodynamic changes during intubation

  T1-before induction T2-immediately after induction

Study Arms (2)

Group R (research group)

EXPERIMENTAL

pediatric patients in this group will be achieve sevoflurane inhalational+propofol intravenous anesthesia induction for nasotracheal intubation

Drug: reduced pharmacologic exposure

group C (conventional group)

ACTIVE COMPARATOR

pediatric patients in this group will be achieve sevoflurane inhalational+propofol+fentanyl+rocuronium intravenous anesthesia induction for nasotracheal intubation

Drug: conventional anesthetic induction

Interventions

reduced pharmacologic exposure DRUG

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

Also known as: propofol+sevoflurane

Group R (research group)

conventional anesthetic induction DRUG

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

Also known as: sevoflurane+propofol+fentanyl+rocuronium

group C (conventional group)

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Dragos Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 2, 2026
• Study Start: July 10, 2026
• Primary Completion: July 29, 2026
• Study Completion: July 29, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (1)