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

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

Interventions

DRUG

Opioids

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.

Sponsors & Collaborators

• Konya City Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-05

Primary Completion

2026-09-15

Completion

2026-10-25

Countries

• Turkey (Türkiye)

Study Locations