Different Anesthetic Approaches on Postoperative Emergence Agitation in Pediatric Patients Undergoing Adenotonsillectomy: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain in PACU (FLACC score)
研究概览
简要总结
Background: Adenotonsillectomy is one of the most common pediatric surgeries and is often complicated by postoperative emergence agitation (POEA), a short-lived but distressing state of confusion and restlessness after anesthesia. POEA may decrease comfort and increase the risk of perioperative complications.
Objective: To compare four commonly used anesthetic strategies-propofol bolus, ketamine bolus, lidocaine infusion, and magnesium sulfate infusion-with respect to POEA and early recovery quality in children undergoing adenotonsillectomy.
Methods: In this single-center, prospective randomized trial, 100 children aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II scheduled for adenotonsillectomy were assigned to one of four anesthetic groups. All patients received standardized premedication, intraoperative management, and multimodal analgesia. Postoperative complications, analgesic requirements, postoperative nausea and vomiting (PONV), time to eye opening, duration of stay in the post-anesthesia care unit (PACU), vital signs, Face, Legs, Activity, Cry, Consolability (FLACC) pain score , Pediatric Anesthesia Emergence Delirium (PAED) score, Modified Aldrete Score (MAS) were recorded and compared.
详细描述
Adenotonsillectomy operations are the most common childhood surgeries. Although they are so common, still adenotonsillectomy procedures remain challenging with increased risks of morbidity and mortality for both the surgeon and the anesthesiologist .
Postanesthetic emergence agitation (POEA) is a temporary state of dissociated consciousness during recovery from general anesthesia, in which the child is irritable, uncooperative, restless, and often crying. Reported incidence ranges from 10% to 80%, and POEA is particularly common after ear, nose, and throat (ENT) procedures, including adenotonsillectomy. POEA is usually self-limited, children suffer anxiety, fasting , they are afraid of uncertainty, pain and seperation from parents .POEA needs special consideration because it may lead to self-injury, disruption of surgical sites, removal of catheters or tubes, and delayed discharge from the post-anesthesia care unit (PACU).
Various pharmacological strategies have been investigated to reduce POEA, including propofol, ketamine, magnesium sulfate, lidocaine, opioids, benzodiazepines, clonidine, and α2-agonists, with conflicting results . However, the optimal anesthetic strategy to minimize POEA while preserving efficient recovery remains unclear. The investigators therefore designed a prospective randomized study to compare four anesthetic approaches-propofol, ketamine, lidocaine, and magnesium sulfate-on POEA incidence, recovery characteristics, and perioperative complications in children undergoing adenotonsillectomy.
Methods This prospective randomized study was conducted at Gaziosmanpaşa Research and Training Hospital. The study protocol was approved by the institutional Ethics Committee, and written informed consent was obtained from the parents or legal guardians of all participants. The investigators enrolled 100 pediatric patients aged 3-10 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective adenotonsillectomy. Exclusion criteria included ASA III or higher, emergency surgery, communication barriers, history of allergy to any study medication, and known cognitive or developmental delay. All children were fasted according to standard guidelines.
Patients were randomized into four groups using a computer-generated sequence:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study medications (propofol, ketamine, lidocaine, and magnesium sulfate) are prepared by an anesthesiologist who is involved in intraoperative management . Postop assessment is done by another anesthesiologist. Postoperative outcome assessors remain blinded to group allocation until completion of data collection and database lock.
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients aged 3-10 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •scheduled for elective adenotonsillectomy
排除标准
- •ASA III or higher
- •emergency surgery
- •communication barriers
- •history of allergy to any study medication
- •known cognitive or developmental delay.
研究组 & 干预措施
Magnesium sulfate (MgSO4) group
All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen.
Participants additionally received MgSO4 infusion per protocol (loading dose 30 mg/kg over 10 minutes after intubation, followed by 10 mg/kg/h infusion).
干预措施: Magnesium sulfate (MgSO4) infusion (Drug)
Propofol group
All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen.
Participants additionally received propofol 1 mg/kg bolus before the end of surgery.
干预措施: Propofol bolus (Drug)
Ketamine group
All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen.
Participants additionally received ketamine 2 mg/kg bolus administered after induction.
干预措施: Ketamine bolus (Drug)
Lidocaine group
All patients received the same premedication (IV midazolam 0.1 mg/kg) and standardized induction with fentanyl 1 μg/kg, propofol 2 mg/kg, and rocuronium 0.5 mg/kg. After tracheal intubation, anesthesia was maintained with sevoflurane in an oxygen/air mixture. At the end of surgery, all patients received dexamethasone 0.2 mg/kg and acetaminophen 20 mg/kg IV as part of a multimodal analgesic regimen.
Participants additionally received lidocaine 1.5 mg/kg infusion over 15 minutes after induction.
干预措施: Lidocaine Infusion (Drug)
结局指标
主要结局
Postoperative pain in PACU (FLACC score)
时间窗: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
Postoperative pain will be assessed in the post-anesthesia care unit (PACU) using the Face, Legs, Activity, Cry, Consolability (FLACC) pain score (range 0-10; higher scores indicate more severe pain). FLACC will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. Primary metric will be the maximum FLACC recorded within 120 minutes after PACU arrival.
Emergence agitation/delirium in PACU (PAED score)
时间窗: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
Emergence agitation/delirium will be assessed in the PACU using the Pediatric Anesthesia Emergence Delirium (PAED) score (range 0-20; higher scores indicate more severe agitation/delirium). PAED will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the maximum PAED score observed within the first 2 hours in the PACU. Primary metric will be the maximum PAED recorded within 120 minutes after PACU arrival.
Early recovery status in PACU (Modified Aldrete Score, MAS)
时间窗: From PACU arrival (0 minutes) up to 120 minutes postoperatively, assessed at PACU arrival and at 5, 15, and 120 minutes after PACU arrival.
Recovery status will be assessed in the PACU using the Modified Aldrete Score (MAS) (range 0-10; higher scores indicate better recovery). MAS will be recorded by a trained observer at PACU arrival and at predefined time points up to 2 hours postoperatively. The primary metric will be the minimum MAS observed within the first 2 hours in the PACU.
次要结局
- postoperative nausea and vomiting (PONV)(From PACU arrival (0 minutes) up to 120 minutes postoperatively)
- Time to eye opening after discontinuation of anesthetic agents(From discontinuation of anesthetic agents at the end of surgery to the time of first spontaneous eye opening, assessed from end of surgery up to 2 hours postoperatively)
- Length of stay in the post-anesthesia care unit (PACU)(From PACU arrival until PACU discharge up to 120 minutes)
研究者
Ayfer Kaya Gök
Medical doctor
Gaziosmanpasa Research and Education Hospital