Emergence Delirium (Derlenme Deliryumu)
Conditions
Keywords
emergence delirium, pediatric anesthesia, bispectral index, anesthetic depth, adenoidectomy, tonsillectomy
Brief summary
The goal of this clinical trial was to learn if using a brain monitor to adjust anesthesia (sleep medicine) during surgery could prevent emergence delirium (severe confusion and agitation upon waking) in children aged 2 to 12 years having their tonsils or adenoids removed. The main questions it aimed to answer were: Did using a brain monitor lower the chance of children waking up confused and upset? Did using the brain monitor reduce the amount of anesthesia gas (sevoflurane) needed during surgery, and did it affect recovery time or pain levels? Researchers compared anesthesia adjusted using a bispectral index (BIS) brain monitor to anesthesia adjusted using standard care to see if the brain monitor lowered the chance of emergence delirium. Participants in the study: Received general anesthesia (a standardized mix of inhaled and intravenous medicines, including sevoflurane and fentanyl) to safely sleep through surgery to remove their tonsils or adenoids Had the dose of their main anesthesia gas (sevoflurane) adjusted during surgery based on either brain monitor readings (targeting a specific sleep depth of 40-60) or standard physical responses (like heart rate and blood pressure) Were checked by the research team immediately after waking up to measure their confusion, agitation, and pain using standard clinical rating scales
Detailed description
Emergence delirium (ED) represents a significant neurobehavioral complication that frequently occurs during the immediate postoperative period in pediatric populations, particularly following otorhinolaryngological procedures such as adenoidectomy and tonsillectomy. Characterized by severe agitation, altered awareness, disturbed psychomotor behavior, and inconsolability, ED poses safety risks to the recovering patient and increases the burden on healthcare providers and caregivers. While the etiology of ED is multifactorial, the intraoperative depth of anesthesia and the cumulative exposure to specific volatile anesthetics, such as sevoflurane, are known modifiable risk factors. Both excessively deep and inadequately light anesthesia can contribute to poor recovery profiles. The Bispectral Index (BIS) is an electroencephalogram (EEG)-based monitor that provides an objective measurement of a patient's level of consciousness, allowing anesthesiologists to precisely titrate anesthetic agents to an optimal depth. This prospective, randomized controlled study was designed to investigate the role of BIS-guided anesthetic titration in mitigating the risk of ED. Upon enrollment, pediatric patients undergoing adenoidectomy and/or tonsillectomy were randomized into one of two clinical care pathways: a BIS-guided anesthesia group or a standard-care group. To ensure baseline consistency across the study, all participants followed a standardized anesthetic induction protocol. Following routine premedication, general anesthesia was induced using inhaled sevoflurane combined with intravenous lidocaine, rocuronium (for muscle relaxation), and fentanyl (for analgesia). For the maintenance phase of anesthesia, patients in both arms received a combination of inhaled sevoflurane and continuous remifentanil infusions. The critical divergence in the study protocol occurred during the intraoperative maintenance phase: BIS-Guided Pathway: Anesthesiologists continuously monitored the patient's EEG activity using the BIS monitor. The concentration of the sevoflurane gas was deliberately titrated to maintain a BIS value between 40 and 60, which represents an optimal and safe depth for surgical anesthesia. By keeping patients within this precise target range, the protocol systematically avoided periods of excessively deep (BIS \< 40) or overly light (BIS \> 60) anesthesia. Standard-Care Pathway: Anesthesiologists adjusted the sevoflurane concentrations based entirely on traditional clinical signs and autonomic responses, specifically monitoring hemodynamic fluctuations such as heart rate and blood pressure, without the use of EEG-guided depth parameters. Following the completion of the surgical procedure, patients were transferred to the post-anesthesia care unit (PACU) for close observation. The clinical team systematically evaluated the patients' transition from unconsciousness to wakefulness. To ensure a robust, multi-faceted assessment of neurobehavioral status, the clinical staff utilized three validated behavioral assessment tools: the Pediatric Anesthesia Emergence Delirium (PAED) scale, the Watcha scale, and the Cravero scale. Simultaneously, postoperative physical pain was managed and tracked using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale. If a patient exhibited signs meeting predetermined thresholds for severe emergence delirium (specifically, a PAED score of 10 or higher, a Watcha score of 3 to 4, or a Cravero score of 4 or higher), the clinical protocol dictated the administration of intravenous fentanyl as a rescue pharmacological intervention to safely manage the agitation. Through this methodology, the study sought to define the relationship between strict, brain-monitored anesthetic titration and postoperative behavior. It comprehensively evaluated how preventing fluctuations in anesthetic depth impacts overall volatile anesthetic consumption, the necessity for rescue opioids in the recovery room, and the overall quality and speed of pediatric recovery following airway surgery.
Interventions
DEVICEBIS-Guided Anesthesia
Anesthetic depth was continuously guided by the Bispectral Index (BIS) monitor. A single-use BIS sensor was placed on the patient's forehead before anesthesia induction to record real-time EEG activity. The primary inhaled anesthetic (sevoflurane) was continuously titrated throughout the surgery to strictly maintain a BIS value within the target range of 40 to 60. If the BIS value dropped below 40, the sevoflurane concentration was decreased. If the BIS value exceeded 60, the continuous remifentanil infusion (0.02-0.1 mcg/kg/min) was increased first, followed by an increase in sevoflurane if necessary. Intervention
DRUGStandard Care Anesthesia
Anesthetic depth was guided solely by traditional clinical signs and autonomic responses. The primary inhaled anesthetic (sevoflurane) was initiated at a 1% end-tidal concentration and adjusted in 0.25% increments (range 0.50% to 1.5%) to maintain the patient's heart rate and blood pressure within ±25% of their baseline pre-anesthesia values. Remifentanil was also infused continuously (0.02-0.1 mcg/kg/min) and adjusted based on clinical requirements. A BIS sensor was attached to the patient to record data, but the monitor screen was completely blinded to the anesthesia care provider, ensuring titration relied exclusively on standard hemodynamic metrics.
Sponsors
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
This was a single-blind clinical trial. Participants and their guardians were masked to the study arm assignment. Anesthesia care providers could not be masked to the intervention assignment itself, as they were required to actively titrate the anesthesia based on the assigned method. However, a specific masking protocol was used for the active comparator group to prevent bias. In the standard care group, the BIS monitor was applied to the patient to record data, but the screen was completely covered. This ensured the care provider remained masked to the actual BIS values during the surgery, forcing them to rely solely on standard hemodynamic-guided titration.
Intervention model description
This study utilized a parallel assignment model. A total of 125 pediatric patients (aged 2 to 12 years) undergoing adenoidectomy and/or tonsillectomy were randomized in a 1:1 ratio into two distinct, simultaneous arms: the intervention group (BIS-guided anesthesia) and the active comparator group (standard care). During the intraoperative phase, both groups received identical anesthetic agents (sevoflurane and remifentanil). The fundamental difference between the parallel arms was the titration strategy. In the BIS arm, sevoflurane was titrated continuously to maintain a strict Bispectral Index target of 40-60. In the standard-care arm, anesthesiologists adjusted the sevoflurane dosage based entirely on traditional clinical and hemodynamic responses, such as heart rate and blood pressure. Participants remained in their initially assigned arms for the entire duration of the surgery and the postoperative recovery observation period. No crossover design was utilized.
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children between the ages of 2 and 12 years * Scheduled for a planned surgery to remove adenoids, tonsils, or both * Generally healthy or having only mild medical conditions (American Society of Anesthesiologists class I or II) * Expected to have a surgery that lasts less than 4 hours * Having the procedure as an outpatient and expected to go home the same day
Exclusion criteria
* Having severe medical conditions (American Society of Anesthesiologists class III or IV) * Having a known history of neurological or psychiatric diseases * Diagnosed with a developmental delay * Having severe heart, lung, or metabolic conditions * Having a known allergy to any of the medications used in the study * Parents or legal guardians refuse to provide written consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure 1: Incidence of Emergence Delirium Assessed by the PAED Scale | Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation. | Evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale ranges from a minimum of 0 to a maximum of 20. Higher scores mean a worse outcome (more severe delirium). Scores of 10 or higher were classified as a positive diagnosis for emergence delirium. |
| Primary Outcome Measure 2: Incidence of Emergence Delirium Assessed by the Watcha Scale | Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation. | Evaluated postoperatively using the Watcha behavioral scale. The scale ranges from a minimum of 1 to a maximum of 4. Higher scores mean a worse outcome (greater agitation and delirium). Scores of 3 to 4 were classified as a positive diagnosis for emergence delirium. |
| Primary Outcome Measure 3: Incidence of Emergence Delirium Assessed by the Cravero Scale | Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation. | Evaluated postoperatively using the Cravero behavioral scale. The scale ranges from a minimum of 1 to a maximum of 5. Higher scores mean a worse outcome (greater agitation). Scores of 4 or higher were classified as a positive diagnosis for emergence delirium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sevoflurane Consumption | Intraoperative (From anesthesia induction until the completion of surgery). | The total volume of sevoflurane anesthetic gas consumed during the surgical procedure was measured in milliliters (mL). |
| Postoperative Pain Assessed by the FLACC Scale | Postoperative minutes 5, 10, 15, 30, 45, and 60 following extubation. | Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores mean a worse outcome (more severe pain). Scores of 4 or higher indicated the presence of pain. |
| Rescue Opioid Usage | Up to 60 minutes during the post-anesthesia recovery period. | Administration of intravenous rescue fentanyl (administered at a dose of 1-2 mcg/kg) as an intervention for severe emergence delirium or inadequate pain control. |
| Recovery Time | Up to 4 hours (From transfer to the recovery unit until discharge criteria were successfully met). | Time required to meet safe discharge criteria from the post-anesthesia care unit, determined by the Modified Aldrete Score. The scale ranges from 0 to 10; higher scores mean a better outcome. A score of 9 or higher indicates readiness for discharge. |
Countries
Turkey (Türkiye)
Outcome results
None listed