A Phase 4 interventional study of Opioids in Emergence Delirium, Emergence Agitation and Anesthesia Recovery Period, sponsored by Konya City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Konya City Hospital · Phase 4, Interventional, and Treatment
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.
Background and Rationale
Emergence delirium, also termed emergence agitation, is a postoperative complication of pediatric anesthesia characterized by disturbances of perception and psychomotor behavior. It presents as a dissociative state of consciousness in which the child is restless, crying, non-cooperative, incoherent, inconsolable, or thrashing in bed. Reported incidence ranges from 25% to 80%, is higher in children under six years of age, and is observed most frequently after anesthesia with the volatile agents sevoflurane and desflurane.
Emergence delirium is not a self-limited nuisance. Affected children are at increased risk of inadvertent removal of intravenous cannulae, self-injury, and postoperative nausea and vomiting. The condition adversely affects recovery and well-being, prolongs hospital length of stay, increases health care costs, and may be followed by maladaptive behavioral change persisting for weeks after anesthesia.
Short-acting opioids, including fentanyl and remifentanil, are used in children both as sedatives and analgesics and to blunt the hemodynamic response to surgical stimulation and airway instrumentation; they have also been evaluated as preventive agents for emergence agitation. Remifentanil is attractive because of its rapid onset, absence of accumulation, and short context-sensitive half-time. However, published trials of remifentanil and emergence agitation under sevoflurane anesthesia are inconsistent: infusion-based regimens have been reported both to reduce and to increase the incidence of agitation. This trial is designed to resolve that inconsistency in a defined pediatric surgical population by directly comparing fentanyl with remifentanil maintenance, and to examine the relationship between intraoperative remifentanil use and the quality of postoperative recovery.
Objectives and Hypotheses
The primary objective is to compare the effect of intraoperative remifentanil versus fentanyl maintenance on the occurrence of postoperative emergence delirium. The primary hypothesis is that remifentanil produces less delirium than fentanyl in pediatric urologic surgery. The secondary objective is to examine the effect of remifentanil on the postoperative recovery process, with the hypothesis that its effect is dose-dependent and that higher infusion rates may deepen intraoperative hypotension.
Study Design and Conduct
This is a single-center, parallel-group, randomized controlled trial conducted with institutional review board approval, written informed consent from a parent or legal guardian, and assent from the child. Consent includes permission for data sharing with the research coordination center at the University of Health Sciences, Konya City Hospital. Participants are allocated in a 1:1 ratio to Group F (fentanyl) or Group R (remifentanil).
Anesthetic Protocol
All children receive intravenous midazolam 0.05 mg/kg five minutes before entering the operating room and are monitored with electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and capnography. Anesthesia is induced with propofol 3-5 mg/kg. After loss of consciousness, Group F receives fentanyl 1 μg/kg as a bolus followed by 1 μg/kg intravenously every 30 minutes until the end of surgery, and Group R receives remifentanil 0.5 μg/kg followed by a continuous infusion of 1 μg/kg/min. In both groups a laryngeal mask airway is inserted 90 seconds after the bolus dose, and anesthesia is maintained with sevoflurane titrated to 1 MAC together with the assigned opioid. Immediately after induction, all patients receive preemptive intravenous paracetamol and ketamine 0.3 mg/kg.
At the end of surgery, sevoflurane and the assigned opioid are discontinued. The laryngeal mask airway is removed once the child shows a regular respiratory pattern and purposeful movement of the extremities without physical stimulation. Children are then observed in the post-anesthesia care unit, where emergence behavior, recovery milestones, and hemodynamic data are recorded, and are transferred to the ward after a further 30 minutes of observation once post-anesthesia discharge criteria are met.
Statistical Considerations
The sample size was projected from a previously published observational study of emergence and postoperative delirium. Assuming an emergence delirium prevalence of approximately 15.75%, 90% power, a two-sided alpha of 0.05, and an allowance of 4.91% for protocol deviations and adverse events, 88 participants per group (176 in total) were required.
Normality of distribution is assessed with the Shapiro-Wilk test. Demographic data and scale scores are summarized descriptively as mean ± standard deviation or as counts and percentages. Between-group comparisons of continuous variables are made with the independent-samples t test, and relationships between variables are examined by correlation analysis with reporting of confidence intervals. A two-sided P value \< 0.05 is considered statistically significant.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 88 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Konya City Hospital is the lead sponsor of 81 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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 frame: 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
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 frame: From discontinuation of sevoflurane to laryngeal mask airway removal, assessed up to 30 minutes
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 frame: From discontinuation of sevoflurane to eye opening, assessed up to 30 minutes
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.
Time frame: 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
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.
Time frame: From induction of anesthesia to the end of surgery, assessed up to 4 hours
Duration of surgery Description: Interval from surgical
nterval from surgical incision to completion of the surgical procedure, recorded in minutes.
Time frame: From surgical incision to completion of surgery, assessed up to 4 hours
Intraoperative heart rate
Heart rate in beats per minute recorded at baseline before induction, after induction, after laryngeal mask airway placement, at surgical incision, at 15-minute intervals during surgery, and at the end of surgery. Reported as mean and standard deviation per arm at each time point.
Time frame: From before induction to the end of surgery, assessed up to 4 hours
Intraoperative mean arterial pressure
mean arterial pressure in mmHg, recorded at baseline
Time frame: From before induction to the end of surgery, assessed up to 4 hours
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 50 non-industry phase 4 interventional studies under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's planned 3 months is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 11 and three quarters within 33.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Sep 2026 → Dec 2026 and completion Oct 2026 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Opioids
Konya City Hospital