Health TrialsbyHealthPanel

Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.

ConditionIntubating Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorBezmialem Vakif University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

elective dental surgery ASA 1-3 Age 1-10

Disqualifiers

anticipated difficult intubation

vocal cord pathology or disease

hoarssness

Trial design

Design model

Parallel

Treatments tested in this trial

  • reduced pharmacologic exposure

    Drug

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

  • conventional anesthetic induction

    Drug

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Group R (research group)Experimental treatment 1 intervention
Group B: group C (conventional group)Active comparator 1 intervention

Trial outcomes

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.

Time frame
during direct laryngoscopy

Secondary outcomes

1

Hemodynamic changes during intubation

Mean arterial pressure (mmHg)

Time frame
T1- before induction T2 - immediately after induction
2

postoperative side effects

laryngospasm (yes/no)

Time frame
immediately after extubation
3

Hemodynamic changes during intubation

Systolic Blood Pressure (mmHg)

Time frame
T1-before induction T2-immediately after induction
4

Hemodynamic changes during intubation

Diastolic blood pressure (mmHg)

Time frame
T1-before induction T2-immediately after induction

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bezmialem Vakif University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: