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Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia

ConditionSevoflurane Consumption
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorTC Erciyes University

About this trial

This study will evaluate whether pre-emptive local anesthesia reduces sevoflurane consumption during pediatric day-case dental treatment performed under general anesthesia.

Children aged 4 to 12 years scheduled for elective dental treatment under general anesthesia will be included. Participants will be assigned to either receive pre-emptive local anesthesia before the dental procedure or receive no pre-emptive local anesthesia. General anesthesia will be standardized using sevoflurane, low fresh gas flow, endotracheal intubation, and bispectral index monitoring.

The main outcome will be sevoflurane consumption expressed as mL/kg/hour. Secondary outcomes will include anesthetic agent uptake, time from sevoflurane discontinuation to extubation, and estimated carbon dioxide-equivalent emissions.

The aim is to determine whether pre-emptive local anesthesia can reduce volatile anesthetic requirement and improve early recovery while maintaining adequate anesthetic depth in children undergoing dental general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 4 to 12 years

Scheduled for elective day-case dental treatment under general anesthesia

ASA physical status I or II

Planned sevoflurane-based general anesthesia

Disqualifiers

Age younger than 4 years or older than 12 years

ASA physical status III or higher

Emergency dental procedures

Known allergy or contraindication to sevoflurane

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre-emptive Local Anesthesia

    Procedure/Surgery

    Pre-emptive local anesthesia will be administered before the dental procedure according to the planned dental treatment. The application sites, total volume, total dose, and dose per kilogram will be recorded.

  • Articaine With Epinephrine

    Drug

    Articaine with epinephrine will be used for local anesthesia before the dental procedure in the pre-emptive local anesthesia group. The total administered volume, total dose, dose per kilogram, and injection sites will be recorded.

  • Sevoflurane

    Drug

    Sevoflurane will be used for maintenance of general anesthesia in both study groups. Sevoflurane administration will be titrated to maintain bispectral index values within the target range of 40 to 60 under standardized low-flow anesthesia.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Pre-emptive Local Anesthesia GroupExperimental treatment 3 interventions
Group B: No Pre-emptive Local Anesthesia GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sevoflurane Consumption in mL/kg/hour

Sevoflurane consumption will be obtained from the Dräger Primus logbook at the end of anesthesia. Sevoflurane will be titrated to maintain bispectral index values within the target range of 40 to 60 in both groups. Consumption will be normalized to body weight and sevoflurane administration duration and expressed as mL/kg/hour.

Time frame
Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure

Secondary outcomes

1

Sevoflurane Agent Uptake

Sevoflurane agent uptake will be obtained from the Dräger Primus logbook at the end of anesthesia and recorded in milliliters.

Time frame
Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
2

Carbon Dioxide-Equivalent Emissions From Sevoflurane Consumption

Estimated carbon dioxide-equivalent emissions will be calculated from total sevoflurane consumption using the predefined conversion factor of 0.198 kg CO2e per mL of sevoflurane.

Time frame
Calculated at the end of each procedure using intraoperative sevoflurane consumption
3

Time From Sevoflurane Discontinuation to Extubation

The time interval from discontinuation of sevoflurane to extubation will be recorded in minutes.

Time frame
Emergence period, from sevoflurane discontinuation to extubation during each procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

TC Erciyes University

Lead sponsor

Source ClinicalTrials.gov

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