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Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia (PEDSEVOLA)

2026年5月20日 更新者:seher orbay yasli、TC Erciyes University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sevoflurane Consumption in mL/kg/hour
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Sevoflurane Agent Uptake
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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