The Effect of Remifentanil on Postoperative Emergence Delirium in Pediatric Urology Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group F: Fentanyl
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.
干预措施: Opioids (Drug)
Group R: Remifentanil
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.
干预措施: Opioids (Drug)
结局指标
主要结局
Incidence of emergence delirium assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
时间窗: 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
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.
次要结局
- Intraoperative heart rate(From before induction to the end of surgery, assessed up to 4 hours)
- Intraoperative mean arterial pressure(From before induction to the end of surgery, assessed up to 4 hours)
- 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)
研究者
Yasin Tire, MD
Assoc. Prof. Dr. Yasin Tire
Konya City Hospital