Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total intraoperative opioid consumption
研究概览
简要总结
This prospective, randomized, single-blind, two-arm parallel-group clinical trial evaluates whether EEG-guided sevoflurane titration affects intraoperative opioid consumption and emergence quality in children undergoing painful elective surgery without regional anesthesia. Children aged 2-8 years (ASA I-II) scheduled for elective tonsillectomy (±adenoidectomy) are randomized 1:1 to a Control Group (standard 1 age-adjusted MAC; EEG screen concealed) or a Study Group (sevoflurane titrated to a stable slow-delta/alpha EEG pattern, SEF 17-20 Hz, starting at ~0.7 MAC). In both arms, fentanyl (0.5-1 mcg/kg IV) is added when nociception signs occur. The primary outcome is intraoperative fentanyl consumption (mean mcg/kg rate). Secondary outcomes include sevoflurane exposure (EtSevo, MAC-hours), EEG burst suppression, emergence time, emergence delirium (PAED scale), postoperative pain and opioid use, and hemodynamic events. Sample size: 50 participants (25/arm; 90% power, α=0.05, expected difference 2 mcg/kg, SD=2). EEG spectral analysis is performed in MATLAB using multitaper frequency-domain bootstrap. The study has institutional ethics approval; parental consent and patient assent (≥7 years) are obtained prior to enrollment.
详细描述
Electroencephalography (EEG)-guided anesthetic titration has demonstrated significant clinical benefits in both pediatric and adult patients. However, proprietary EEG-based indices widely used for monitoring anesthetic depth are affected by patient age and the specific anesthetic agent used, limiting their validity and generalizability. More recently, titrating anesthetics based on a specific interpretation of EEG waveforms and their oscillatory patterns observed on the spectrogram has gained popularity.
Previous studies indicate that sevoflurane titration based on specific EEG waveforms and oscillatory patterns yields more substantial reductions in sevoflurane exposure than previously reported with proprietary EEG indices. Furthermore, reducing sevoflurane exposure decreases the incidence of EEG burst suppression, results in faster emergence times, and reduces emergence delirium.
However, most of these benefits have been reported in the context of surgeries where intraoperative antinociception was provided via central or peripheral nerve blocks, in the absence of increased intraoperative analgesic and opioid requirements. It remains unclear whether the benefits associated with reduced sevoflurane exposure are also observed in surgeries where intraoperative antinociception cannot be provided through regional blocks. In such cases, antinociception depends primarily on the co-administration of inhaled anesthetics and opioids. Therefore, the clinical benefits of decreasing sevoflurane exposure via electroencephalographic guidance must be weighed against the side effects of higher perioperative opioid requirements.
What will be the impact of strict titration of the hypnotic component using electroencephalography in a painful surgery, in terms of intraoperative opioid consumption and the quality of anesthetic emergence? It is hypothesized that to adjust the sevoflurane dose according to EEG targets in children undergoing surgeries where intraoperative antinociception cannot be provided via regional blocks will result in a reduction of sevoflurane requirements. However, a compensatory increase in intraoperative opioid consumption is expected to be observed, which could subsequently affect the quality and duration of the anesthetic recovery period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
The Participant (Patient). From the patient's point of view, this metric directly impacts their comfort, safety, and recovery. While they are completely unconscious during the "intraoperative period" and won't remember the fentanyl being administered, the dosage chosen by the team dictates how smoothly they wake up.
OR and PACU Clinicians and Nurses (Anesthesiologists, CRNAs, Circulating Nurses). Team inherits the results of this intraoperative and postoperative tracking during the handoff report. When they receive the patient, they look at the total mean fentanyl rate administered in the OR to anticipate the patient's immediate post-op needs.
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-8 years
- •ASA Physical Status I or II
- •Elective tonsillectomy (±adenoidectomy)
- •Signed parental consent (and assent ≥7 years)
排除标准
- •Neurological or psychiatric disorders
- •Growth or developmental delay
- •Known allergy to study medications
- •Coagulation disorders
- •Parental or patient refusal
研究组 & 干预措施
Control Group
Induction with sevoflurane 5% in O₂. Maintenance at fixed 1 age-adjusted MAC in O₂/air FiO₂ 60%. BIS monitor attached but screen concealed; anesthesiologist blinded to EEG data.
干预措施: Standard (Procedure)
Intervention Group
Induction with sevoflurane 3% in O₂. Maintenance titrated to the minimum concentration sustaining a continuous slow-delta/alpha EEG pattern (SEF 17-20 Hz), starting at 0.7 age-adjusted MAC in O₂/air FiO₂ 60%.
干预措施: EEG-guided (Procedure)
结局指标
主要结局
Total intraoperative opioid consumption
时间窗: Intraoperative period
Mean fentanyl rate (mcg/kg).
次要结局
- EEG spectral markers_TBP(Intraoperative period)
- EEG spectral markers_MedF(Intraoperative period)
- Sevoflurane exposure(Intraoperative period)
- EEG burst suppression(Intraoperative period)
- EEG spectral markers_SEF95(Intraoperative period)
- hemodynamic, Bradicardia(Intraoperative period)
- hemodynamic, hypotension(Intraoperative period)
- emergence time(From end of anesthesia period to extubation)
- Eye opening, emergence time(From end of anesthesia period to extubation)
- emergence delirium(Post anesthesia period)
- Postoperative pain(Post anesthesia period)
- Rescue analgesia(Post anesthesia period)
- postoperative opioid use(Post anesthesia period)