Sevoflurane ConsumptionPEDSEVOLANCT07608900
Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia
A study testing Pre-emptive Local Anesthesia, Articaine With Epinephrine and Sevoflurane in people with Sevoflurane Consumption, run by TC Erciyes University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Sevoflurane Consumption
- What is being tested?
- Pre-emptive Local Anesthesia, Articaine With Epinephrine and Sevoflurane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Planned oral endotracheal intubation
- Eligibility for standardized low-flow anesthesia with fresh gas flow of 1 L/min
- Eligibility for BIS-guided sevoflurane titration
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- 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
- Known allergy or contraindication to amide local anesthetics, articaine, or epinephrine
- Known or suspected malignant hyperthermia susceptibility
Show all 11Show fewer
- Significant cardiovascular, respiratory, hepatic, renal, or neurological disease requiring non-standard anesthetic management
- Chronic opioid or sedative use
- Planned airway management other than oral endotracheal intubation
- Dental procedures in which withholding pre-emptive local anesthesia is considered clinically inappropriate for safety or hemostasis
- Refusal of participation by parent or legal guardian
About this study
Official title: Effect of Pre-emptive Local Anesthesia on Sevoflurane Consumption, Agent Uptake, and Carbon Footprint in Pediatric Day-case Dental General Anesthesia: A Prospective Randomized Controlled 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.
Read more
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.
Read the detailed description
Pediatric dental procedures are frequently performed under general anesthesia, particularly in children who require multiple dental treatments or who cannot tolerate dental treatment under local anesthesia alone. Sevoflurane is commonly used for pediatric anesthesia because of its favorable pharmacological profile and rapid emergence. However, volatile anesthetic consumption is associated with cost and environmental impact, and strategies that safely reduce volatile anesthetic requirements are clinically relevant.
Pre-emptive local anesthesia may reduce nociceptive input during dental procedures and thereby decrease the requirement for volatile anesthetic agents. In pediatric dental general anesthesia, this approach may also influence early recovery. This prospective randomized controlled study will investigate the effect of pre-emptive local anesthesia on sevoflurane consumption, anesthetic uptake, recovery parameters, rescue analgesic requirement, and environmental impact in children undergoing day-case dental treatment under general anesthesia.
Children aged 4 to 12 years scheduled for elective day-case dental treatment under general anesthesia will be enrolled according to eligibility criteria. Participants will be allocated to one of two parallel groups: a pre-emptive local anesthesia group and a no pre-emptive local anesthesia group. In the pre-emptive local anesthesia group, local anesthesia will be administered before the dental procedure according to the dental treatment plan. In the control group, no routine pre-emptive local anesthesia will be administered. Rescue local anesthesia, if required for clinical reasons, will be recorded separately.
Anesthetic management will be standardized. Airway management will be performed with oral endotracheal intubation. Fresh gas flow will be maintained at 1 L/min unless a safety-related increase is required. If fresh gas flow is increased, the duration and reason will be recorded. Sevoflurane will be titrated to maintain bispectral index values within the target range of 40 to 60. Intraoperative hemodynamic variables, end-tidal carbon dioxide, bispectral index, inspired and end-tidal sevoflurane concentrations, and minimum alveolar concentration values will be recorded at predefined time points.
The primary outcome will be sevoflurane consumption normalized to body weight and anesthesia duration, expressed as mL/kg/hour. Total sevoflurane consumption and anesthetic agent uptake will be obtained from the Dräger Primus logbook at the end of anesthesia. The uptake ratio will be calculated as agent uptake divided by total sevoflurane consumption multiplied by 100.
Early recovery will be assessed using predefined time points, including sevoflurane discontinuation time, extubation time, first bispectral index value of 80 or higher, and eye opening time. Recovery in the post-anesthesia care unit will be evaluated using PACU stay duration and the time to reach an Aldrete score of 9 or higher. Rescue fentanyl use, additional analgesic requirement, postoperative nausea and vomiting, and intraoperative complications will be recorded.
The dental procedure burden will be quantified using a procedural burden score based on the number and type of dental procedures performed. This score will include restorations, pulpal or endodontic procedures, simple extractions, and surgical extractions. The procedural burden score will be used to describe and adjust for differences in dental treatment intensity between groups.
Environmental and economic outcomes will be estimated using total sevoflurane consumption. Carbon dioxide-equivalent emissions will be calculated using a predefined conversion factor, and sevoflurane cost will be calculated using the unit price per milliliter.
This study is designed to determine whether pre-emptive local anesthesia provides a volatile anesthetic-sparing effect during low-flow pediatric dental general anesthesia and whether this is associated with improved early recovery, reduced rescue analgesic requirement, lower anesthetic cost, and reduced estimated environmental impact.
- Conditions
- Sevoflurane Consumption
- Being tested
- Pre-emptive Local Anesthesia, Articaine With Epinephrine, Sevoflurane
- Keywords
- Pediatric dental anesthesia, Sevoflurane, Sevoflurane consumption, Pre-emptive local anesthesia, Agent uptake, Carbon footprint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-emptive Local AnesthesiaProcedure or 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 EpinephrineDrug
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.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Local Anesthesia Group | Experimental | Children randomized to this group will receive pre-emptive local anesthesia before the dental procedure under standardized low-flow sevoflurane-based general anesthesia. Receives: Procedure: Pre-emptive Local Anesthesia; Drug: Articaine With Epinephrine; Drug: Sevoflurane |
| No Pre-emptive Local Anesthesia Group | Active comparator | Children randomized to this group will not receive routine pre-emptive local anesthesia before the dental procedure. Rescue local anesthesia, if clinically required, will be recorded separately. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
Secondary outcomes (3)
Sevoflurane Agent Uptake
Sevoflurane agent uptake will be obtained from the Dräger Primus logbook at the end of anesthesia and recorded in milliliters.
Measured: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
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.
Measured: Calculated at the end of each procedure using intraoperative sevoflurane consumption
Time From Sevoflurane Discontinuation to Extubation
The time interval from discontinuation of sevoflurane to extubation will be recorded in minutes.
Measured: Emergence period, from sevoflurane discontinuation to extubation during each procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sevoflurane ConsumptionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups. Children in the pre-emptive local anesthesia group will receive local anesthesia before the dental procedure under general anesthesia. Children in the control group will not receive routine pre-emptive local anesthesia. General anesthesia management, airway management, fresh gas flow, and BIS-guided sevoflurane titration will be standardized in both groups.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher orbay yasli, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608900
- Sponsor's protocol ID
- PED-DENT-SEVO-LA-01
- Acronym
- PEDSEVOLA
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-emptive Local Anesthesia on Sevoflurane Consumption, Agent Uptake, and Carbon Footprint in Pediatric Day-case Dental General Anesthesia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07608900
- Acronym / sponsor ID
- PEDSEVOLA / PED-DENT-SEVO-LA-01
- Conditions
- Sevoflurane Consumption
- Keywords
- Pediatric dental anesthesia, Sevoflurane, Sevoflurane consumption, Pre-emptive local anesthesia, Agent uptake, Carbon footprint
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pediatric dental procedures are frequently performed under general anesthesia, particularly in children who require multiple dental treatments or who cannot tolerate dental treatment under local anesthesia alone. Sevoflurane is commonly used for pediatric anesthesia because of its favorable pharmacological profile and rapid emergence. However, volatile anesthetic consumption is associated with cost and environmental impact, and strategies that safely reduce volatile anesthetic requirements are clinically relevant.
Pre-emptive local anesthesia may reduce nociceptive input during dental procedures and thereby decrease the requirement for volatile anesthetic agents. In pediatric dental general anesthesia, this approach may also influence early recovery. This prospective randomized controlled study will investigate the effect of pre-emptive local anesthesia on sevoflurane consumption, anesthetic uptake, recovery parameters, rescue analgesic requirement, and environmental impact in children undergoing day-case dental treatment under general anesthesia.
Children aged 4 to 12 years scheduled for elective day-case dental treatment under general anesthesia will be enrolled according to eligibility criteria. Participants will be allocated to one of two parallel groups: a pre-emptive local anesthesia group and a no pre-emptive local anesthesia group. In the pre-emptive local anesthesia group, local anesthesia will be administered before the dental procedure according to the dental treatment plan. In the control group, no routine pre-emptive local anesthesia will be administered. Rescue local anesthesia, if required for clinical reasons, will be recorded separately.
Anesthetic management will be standardized. Airway management will be performed with oral endotracheal intubation. Fresh gas flow will be maintained at 1 L/min unless a safety-related increase is required. If fresh gas flow is increased, the duration and reason will be recorded. Sevoflurane will be titrated to maintain bispectral index values within the target range of 40 to 60. Intraoperative hemodynamic variables, end-tidal carbon dioxide, bispectral index, inspired and end-tidal sevoflurane concentrations, and minimum alveolar concentration values will be recorded at predefined time points.
The primary outcome will be sevoflurane consumption normalized to body weight and anesthesia duration, expressed as mL/kg/hour. Total sevoflurane consumption and anesthetic agent uptake will be obtained from the Dräger Primus logbook at the end of anesthesia. The uptake ratio will be calculated as agent uptake divided by total sevoflurane consumption multiplied by 100.
Early recovery will be assessed using predefined time points, including sevoflurane discontinuation time, extubation time, first bispectral index value of 80 or higher, and eye opening time. Recovery in the post-anesthesia care unit will be evaluated using PACU stay duration and the time to reach an Aldrete score of 9 or higher. Rescue fentanyl use, additional analgesic requirement, postoperative nausea and vomiting, and intraoperative complications will be recorded.
The dental procedure burden will be quantified using a procedural burden score based on the number and type of dental procedures performed. This score will include restorations, pulpal or endodontic procedures, simple extractions, and surgical extractions. The procedural burden score will be used to describe and adjust for differences in dental treatment intensity between groups.
Environmental and economic outcomes will be estimated using total sevoflurane consumption. Carbon dioxide-equivalent emissions will be calculated using a predefined conversion factor, and sevoflurane cost will be calculated using the unit price per milliliter.
This study is designed to determine whether pre-emptive local anesthesia provides a volatile anesthetic-sparing effect during low-flow pediatric dental general anesthesia and whether this is associated with improved early recovery, reduced rescue analgesic requirement, lower anesthetic cost, and reduced estimated environmental impact.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups. Children in the pre-emptive local anesthesia group will receive local anesthesia before the dental procedure under general anesthesia. Children in the control group will not receive routine pre-emptive local anesthesia. General anesthesia management, airway management, fresh gas flow, and BIS-guided sevoflurane titration will be standardized in both groups.
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Local Anesthesia Group | Experimental | Procedure: Pre-emptive Local Anesthesia, Drug: Articaine With Epinephrine, Drug: SevofluraneChildren randomized to this group will receive pre-emptive local anesthesia before the dental procedure under standardized low-flow sevoflurane-based general anesthesia. |
| No Pre-emptive Local Anesthesia Group | Active comparator | Drug: SevofluraneChildren randomized to this group will not receive routine pre-emptive local anesthesia before the dental procedure. Rescue local anesthesia, if clinically required, will be recorded separately. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- Planned oral endotracheal intubation
Key exclusion criteria (11 listed)
- 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
- Known allergy or contraindication to amide local anesthetics, articaine, or epinephrine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-emptive Local AnesthesiaPre-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. | Procedure or surgery | Pre-emptive Local Anesthesia Group |
| Articaine With EpinephrineArticaine 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. | Drug | Pre-emptive Local Anesthesia Group |
| SevofluraneSevoflurane 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. | Drug | No Pre-emptive Local Anesthesia Group, Pre-emptive Local Anesthesia Group |
Primary outcome
Sevoflurane Consumption in mL/kg/hour
Time frame: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
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.
3 secondary outcomes
Sevoflurane Agent Uptake
Time frame: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
Carbon Dioxide-Equivalent Emissions From Sevoflurane Consumption
Time frame: Calculated at the end of each procedure using intraoperative sevoflurane consumption
Time From Sevoflurane Discontinuation to Extubation
Time frame: Emergence period, from sevoflurane discontinuation to extubation during each procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-emptive Local Anesthesia, Articaine With Epinephrine and Sevoflurane in people with Sevoflurane Consumption, run by TC Erciyes University.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Sevoflurane Consumption in mL/kg/hour (time frame: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure). 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 27 May 2026.