Emergence Agitation, Emergence Agitation, Post Operative Behavioral Changes, Emergence Delirium, Emergence Delirium, Anesthesia, Emergence Delirium in Pediatric Anesthesia, Emergence From Anesthesia
Conditions
Keywords
emergence agitation, emergence delirium, EA
Brief summary
This study is designed to evaluate the effectiveness of ultrasound-guided greater auricular nerve block (GAN) on the reduction of emergence agitation (EA) occurrence and EA severity in children who are receiving general anesthesia for a microscopic middle ear operation.
Detailed description
Emergence agitation (EA) is one of the Perioperative Neurocognitive Disorders (PND). It's defined as psychomotor agitation and delirium, that typically occurs within the first 45 minutes postoperative. It may present as non-purposeful movements such as kicking and pulling or lack of eye contact or awareness to the surroundings. EA has been linked to several risk factors, including type of surgery (ENT, ophthalmic), the use of volatile anesthetics (especially sevoflurane) . Middle earsurgeries are especially noteworthy because of their high EA risk owing to significant nociceptive stimulation of the external ear and its surrounding tissues as well. Pain is one of the modifiable risk factors, and studies have demonstrated a strong association between postoperative pain scores and incidence of EA The greater auricular nerve (GAN), originating from the cervical plexus (C2-C3), provides sensory innervation to the inferior two-thirds of the auricle, skin over the mastoid process, angle of the mandible and parotid region (5). All these areas are typically involved in or manipulated for middle ear surgery, and therefore the GAN is an easily identifiable nerve for perioperative analgesia treatment. An ultrasound-guided GAN block has been performed in both adults and pediatric populations to provide analgesia for postoperative pain after parotidectomy, auriculotemporal procedures, and mastoid surgery (6,7). The strong association between moderate to severe postoperative pain and EA, coupled with the high rate of EA in middle ear procedures, suggest that a safe, focused regional technique could address these issues in this population (8). That in mind, we hypothesize that using an ultrasound-guided technique giving 100% accuracy blocking GAN, will reduce the pain and hence the incidence of EA postoperative.
Interventions
PROCEDUREultrasound-guided greater auricular nerve block (GANB)
ultrasound-guided greater auricular nerve block (GANB)
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 5 and 14 years (preschool to early school age group at highest risk for EA). * ASA physical status I or II. * Scheduled for elective microscopic middle ear surgery under general anesthesia (e.g., tympanoplasty, myringoplasty). * Ability to comply with FLACC and PAED scoring during postoperative period. * Informed consent obtained from a parent or legal guardian.
Exclusion criteria
* Known neurological, developmental, or psychiatric disorders (e.g., autism, ADHD, seizure disorder). * Known hypersensitivity to amide local anesthetics (e.g., lidocaine, bupivacaine). * Skin infection, hematoma, or trauma at or near the proposed block site. * Non-elective (emergency) or combined surgeries. * Inability to assess pain or agitation due to hearing loss, or communication impairment. * Parental or legal guardian refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| score on Pediatric Anesthesia Emergence Delirium (PAED) scale. | Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative. | The Pediatric Anesthesia Emergence Delirium (PAED) scale has 64% sensitivity and 86% specificity. This validated tool includes five items scored on a 5-point Likert scale (eye contact with caregiver, purposeful actions, awareness of surroundings, restlessness, and consolability). Score of ≥10 at any point during the postoperative observation period in the PACU will be considered as an episode of EA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to emergence | From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes. | It's the time between cessation of any anesthetic agent and emergence, as it contributes to agitation. |
| Postoperative pain intensity | Post-extubation up to 2 hours. | Pain will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, scored from 0 to 10. Pain scores will be assessed: * At 5-minute intervals during the first 30 minutes post-extubation * Then every 15 minutes until PACU discharge * FLACC ≥4 will trigger rescue analgesia with IV nalbuphine (0.1 mg/kg) |
| Requirement for rescue analgesia or rescue sedation | Postoperative from emergence up to 2 hours. | If the incidence of EA or pain occurs, medical intervention will be commenced. |
| Total PACU stay duration | from emergence up to 3 hours. | this will record time to discharge from PACU. The shorter the time the more favorable the intervention is. |
| Incidence of postoperative nausea and vomiting (PONV) | From emergence up to 2 hours. | PONV is considered an adverse outcome of many factors in perioperative period, including opioid use, pain, preoperative GERD or incomplete hours of fasting. |
| Incidence of oxygen desaturation (SpO₂ <94%) | from emergence up to 2 hours. | Hypoxia may result from aspiration, incomplete recovery from muscle relaxants, oversedation, or preexisting respiratory problems. |
Countries
Egypt
Contacts
CONTACTabdalla moustafa abdelhamid, MBBCH
STUDY_CHAIRmohamed ahmed Ismail, professor
Fayoum University
Outcome results
None listed