Emergence delirium (agitation) is a common complication in children recovering from general anesthesia, especially after sevoflurane. Affected children wake in a dissociative state - restless, crying, inconsolable, unaware of their surroundings - with a reported incidence of 25-80%. It raises the risk of self-injury, accidental catheter removal, vomiting, and maladaptive behavior persisting for weeks, and prolongs hospital stay.
Short-acting opioids such as fentanyl and remifentanil are widely used in pediatric anesthesia for sedation and analgesia and to blunt the hemodynamic response to surgical stimulation and airway instrumentation. Both have been proposed to reduce emergence agitation after sevoflurane anesthesia, but findings for remifentanil are inconsistent: some studies report a reduction, others an increase. Clinicians therefore lack clear guidance on opioid selection for maintenance.
This trial compares intraoperative remifentanil with intraoperative fentanyl maintenance on the occurrence of emergence delirium in children undergoing urologic surgery under general anesthesia. Secondary aims are postoperative recovery, duration of surgery, and intraoperative hemodynamics.
Design: single-center randomized controlled trial. 176 children aged 7-12 years, ASA I-II, scheduled for elective pediatric urologic surgery, randomized 1:1 (88 per group).
All participants receive the same background technique: intravenous midazolam 0.05 mg/kg five minutes before entering the operating room; standard monitoring (ECG, pulse oximetry, non-invasive blood pressure, capnography); induction with propofol 3-5 mg/kg; laryngeal mask airway (LMA); sevoflurane titrated to 1 MAC; and preemptive intravenous paracetamol and ketamine 0.3 mg/kg after induction.
The fentanyl group receives fentanyl 1 mcg/kg after loss of consciousness, then 1 mcg/kg every 30 minutes until the end of surgery. The remifentanil group receives remifentanil 0.5 mcg/kg, then an infusion of 1 mcg/kg/min. In both groups the LMA is inserted 90 seconds after the bolus.
At the end of surgery sevoflurane is discontinued and the LMA removed once the child breathes regularly and moves purposefully without stimulation. Emergence delirium is assessed in the post-anesthesia care unit with the Pediatric Anesthesia Emergence Delirium (PAED) scale (0-20). Additional measurements include time from sevoflurane discontinuation to LMA removal, time to eye opening on verbal stimulus, and readiness for discharge.
Age 7 to 12 years
American Society of Anesthesiologists (ASA) physical status I or II
Scheduled for elective pediatric urologic surgery
Surgery planned under general anesthesia with a laryngeal mask airway
History of difficult airway or known airway abnormality
Reactive airway disease
Respiratory tract infection within the preceding 3 weeks
Abnormal cognitive development or developmental delay
Parallel
Opioids
DrugRemifentanil 0.5 microgram/kg intravenously after loss of consciousness, followed by a continuous maintenance infusion of 1 microgram/kg/minute until the end of surgery. And; Fentanyl 1 microgram/kg intravenously after loss of consciousness, followed by 1 microgram/kg intravenously every 30 minutes until the end of surgery.
Incidence of emergence delirium assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Emergence delirium is assessed in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium (PAED) scale by an assessor masked to group allocation. The scale comprises five items, each scored from 0 to 4, giving a total score from 0 to 20, where higher scores indicate more severe emergence delirium. A participant is classified as having emergence delirium if the peak PAED score is 10 or greater at any assessment. The outcome is reported as the proportion of participants in each arm meeting this threshold.
Time to laryngeal mask airway removal
Interval from discontinuation of sevoflurane to removal of the laryngeal mask airway. The airway is removed when the child exhibits a regular respiratory pattern and purposeful movement of the extremities without physical stimulation. Recorded in minutes by a masked assessor.
Time to eye opening
Interval from discontinuation of sevoflurane to eye opening in response to a verbal stimulus. Recorded in minutes by a masked assessor.
Time to post-anesthesia care unit discharge readiness
Interval from arrival in the post-anesthesia care unit to the point at which discharge criteria are met, defined as a modified Aldrete post-anesthesia score greater than 9. The modified Aldrete score assesses activity, respiration, circulation, consciousness and oxygen saturation, each scored 0 to 2, for a total of 0 to 10, with higher scores indicating more complete recovery. Recorded in minutes by a masked assessor.
Incidence of intraoperative hypotension
Proportion of participants experiencing at least one episode of intraoperative hypotension, defined as a fall in mean arterial pressure of more than 20 percent below the pre-induction baseline value, sustained for at least one minute. Non-invasive blood pressure is measured at intervals of no more than 5 minutes throughout surgery.
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