- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07608900
Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia (PEDSEVOLA)
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.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Pre-emptive Local Anesthesia Group
Children randomized to this group will receive pre-emptive local anesthesia before the dental procedure under standardized low-flow sevoflurane-based general anesthesia.
|
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 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 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.
|
|
Aktiver Komparator: No Pre-emptive Local Anesthesia Group
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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sevoflurane Consumption in mL/kg/hour
Zeitfenster: 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.
|
Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sevoflurane Agent Uptake
Zeitfenster: Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
|
Sevoflurane agent uptake will be obtained from the Dräger Primus logbook at the end of anesthesia and recorded in milliliters.
|
Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure
|
|
Carbon Dioxide-Equivalent Emissions From Sevoflurane Consumption
Zeitfenster: Calculated at the end of each procedure using intraoperative 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.
|
Calculated at the end of each procedure using intraoperative sevoflurane consumption
|
|
Time From Sevoflurane Discontinuation to Extubation
Zeitfenster: Emergence period, from sevoflurane discontinuation to extubation during each procedure
|
The time interval from discontinuation of sevoflurane to extubation will be recorded in minutes.
|
Emergence period, from sevoflurane discontinuation to extubation during each procedure
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schwefelverbindungen
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Ethers
- Kohlenwasserstoffe
- Kohlenwasserstoffe, zyklisch
- Kohlenwasserstoffe, aromatisch
- Amine
- Katechole
- Phenole
- Benzolderivate
- Alkohole
- Kohlenwasserstoffe, halogeniert
- Aminoalkohole
- Ethanolamine
- Thiophenes
- Biogene Monoamine
- Biogene Amine
- Katecholamine
- Kohlenwasserstoffe, fluoriert
- Methylether
- Sevofluran
- Adrenalin
- Carticain
Andere Studien-ID-Nummern
- PED-DENT-SEVO-LA-01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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