Hospital UC Christus
Santiago, Región, 450881, Chile
NCT Number: NCT07714785
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.
Looking for future studies?
Notify Me2 year–8 year
All sexes
Interventional
Not applicable
Santiago, Región, 450881, Chile
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%.
Arm Description: 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.
Time frame: Intraoperative period
Mean fentanyl rate (mcg/kg).
Time frame: Intraoperative period
Age-adjusted MAC-hours
Time frame: Intraoperative period
EtSevo
Time frame: Intraoperative period
incidence
Time frame: Intraoperative period
Total band power
Time frame: Intraoperative period
Median frequency
Time frame: Intraoperative period
SEF 95%
Time frame: Intraoperative period
Cumulative duration
Time frame: Intraoperative period
Intraoperative bradycardia (HR<20% basaline) requiring intervention
Time frame: Intraoperative period
intraoperative hypotension (MAP<20% basaline) requiring intervention
Time frame: From end of anesthesia period to extubation
Time from anesthesia discontinuation to extubation
Time frame: From end of anesthesia period to extubation
Time from anesthesia discontinuation to eye opening
Time frame: Post anesthesia period
incidence by paed scale
Time frame: Post anesthesia period
flacc/vas scores
Time frame: Post anesthesia period
Drug use for rescue analgesia non opioids (mg)
Time frame: Post anesthesia period
fentanyl use for pain rescue (mcg)
Pontificia Universidad Catolica de Chile
Other
Impact of EEG-guided Sevoflurane Titration on Opioid Consumption and Emergency Quality in Pediatric Patients Undergoing Surgery Without Regional Anesthesia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07646093
Neurologic Manifestations, Pain
Caracas, Miranda, Venezuela
View Trial DetailsNCT07323485
Confusion, Delirium
Altındağ, Ankara, Turkey (Türkiye)
View Trial DetailsNCT06913205
Acute Pain, Postoperative, Appendectomy, Laparoscopic
Bursa, Turkey (Türkiye)
View Trial DetailsNCT05176119
Confusion, Delirium
Cairo, Al Abbassia, Egypt
View Trial Details