Remifentanil vs Fentanyl in Children 7-12 After Urologic Surgery: Emergence Delirium and Recovery Quality

NCT07800845 | Not Yet Recruiting Phase 4

• 1 other identifier: Study PEREC
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Delirium; Emergence Agitation; Anesthesia Recovery Period; Postoperative Complications; Urologic Surgical Procedures

Keywords

Emergence delirium; Emergence agitation; PAED scale; Pediatric patients.

Outcome Measures

Primary Outcomes (1)

• 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.

  From arrival in the post-anesthesia care unit until discharge criteria are met (modified Aldrete score greater than 9) plus 30 minutes of further observation, assessed up to 2 hours after discontinuation of sevoflurane

Secondary Outcomes (7)

• Time to laryngeal mask airway removal

  From discontinuation of sevoflurane to laryngeal mask airway removal, assessed up to 30 minutes

• Time to eye opening

  From discontinuation of sevoflurane to eye opening, assessed up to 30 minutes

• Time to post-anesthesia care unit discharge readiness

  From arrival in the post-anesthesia care unit until a modified Aldrete score greater than 9 is achieved, assessed up to 2 hours

• Incidence of intraoperative hypotension

  From induction of anesthesia to the end of surgery, assessed up to 4 hours

• Duration of surgery Description: Interval from surgical

  From surgical incision to completion of surgery, assessed up to 4 hours

Study Arms (2)

Group R: Remifentanil

ACTIVE COMPARATOR

Participants receive remifentanil 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. Background anesthesia is identical in both arms: midazolam 0.05 mg/kg premedication, propofol 3-5 mg/kg induction, laryngeal mask airway placed 90 seconds after the bolus, sevoflurane titrated to 1 MAC, and preemptive intravenous paracetamol and ketamine 0.3 mg/kg after induction.

Drug: Opioids

Group F: Fentanyl

ACTIVE COMPARATOR

Participants receive fentanyl 1 microgram/kg intravenously after loss of consciousness, followed by a maintenance dose of 1 microgram/kg intravenously every 30 minutes until the end of surgery. Background anesthesia is identical in both arms: midazolam 0.05 mg/kg premedication, propofol 3-5 mg/kg induction, laryngeal mask airway placed 90 seconds after the bolus, sevoflurane titrated to 1 MAC, and preemptive intravenous paracetamol and ketamine 0.3 mg/kg after induction.

Drug: Opioids

Interventions

Opioids DRUG

Remifentanil 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.

Also known as: Fentanil and Ultiva

Group F: Fentanyl; Group R: Remifentanil

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Written informed consent from a parent or legal guardian, with assent from the child

You may not qualify if:

• 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
• Known allergy to any medication used in the study protocol
• Chronic use of opioids, sedatives, or psychoactive medication

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Complications

Interventions

Analgesics, Opioid; Fentanyl; Remifentanil

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Yasin Tire

CONTACT

05055367970; dryasintire@hotmail.com

Aydın Mermer

CONTACT

05067928318; aydinmer@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are masked. Participants are unconscious when the study opioid is given, having received propofol induction, and neither they nor their parents are told the assigned arm until all postoperative assessments are complete. Outcome assessment is performed by an investigator or recovery unit nurse who is not present in the operating room, takes no part in delivering anesthesia, and is unaware of allocation; this assessor performs all PAED scale scoring and records time to eye opening, time to laryngeal mask airway removal, and the modified Aldrete score. The anesthesia record remains with the operating room team. The attending anesthesiologist cannot be masked, as the arms require different modes of administration. The statistician is masked, with arms coded A and B until analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Yasin Tire

Model Details: Parallel-group design. Participants are randomly assigned 1:1 to one of two arms and remain in that arm throughout; there is no crossover. Both arms receive an identical background anesthetic: midazolam premedication, propofol induction, laryngeal mask airway placement 90 seconds after the study opioid bolus, sevoflurane maintenance at 1 MAC, and preemptive intravenous paracetamol and ketamine. The arms differ only in the maintenance opioid and its mode of delivery: fentanyl as an intravenous bolus followed by intermittent doses every 30 minutes until the end of surgery, or remifentanil as an intravenous bolus followed by a continuous infusion. Because these modes of administration differ, the attending anesthesiologist cannot be masked; emergence delirium is scored in the post-anesthesia care unit by an assessor unaware of allocation. Each participant is assessed once, postoperatively.

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: September 2, 2026
• Study Start: September 5, 2026
• Primary Completion: September 15, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

TU (1)