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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
The anesthesia provider responsible for BIS-guided sevoflurane titration and intraoperative anesthetic management will be blinded to group allocation. The postoperative recovery assessor evaluating PACU stay and Aldrete score will also be blinded to group allocation when feasible. The dental operator administering or not administering local anesthesia cannot be blinded because of the nature of the intervention.
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
seher orbay yasli
Associate Professor
TC Erciyes University