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临床试验/NCT07172594
NCT07172594已完成不适用

Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年9月22日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Incidence of emergence agitation

研究概览

简要总结

This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.

详细描述

Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Lactium is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blinded

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Both gender
  • 4 to 7 years age
  • American Society of Anesthesiologists (ASA) Physical Status I or II
  • Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia

排除标准

  • Parents declined to participate in the trial
  • Children with behavioral changes; neurological or psychiatric diseases
  • Physical or developmental delay
  • Sedative or anticonvulsant medication
  • Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
  • • History of lactose intolerance

研究组 & 干预措施

Lactium group

Experimental

cases will receive preoperative lactium, Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.

干预措施: Lactium (Drug)

Control group

Placebo Comparator

cases will receive 50 ml water added to it powdered vanilla flavor, 2 hours before surgery.

干预措施: Placebo control (Other)

结局指标

主要结局

Incidence of emergence agitation

时间窗: Up to 1 hour after surgery.

Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour

次要结局

  • Parental separation anxiety(Perioperative)
  • Mask Acceptance Score(Perioperative)
  • Postoperative pain(Up to 1 hour after surgery.)
  • Total dose of rescue fentanyl(Up to 1 hour after surgery.)
  • Pediatric Anesthesia Emergence Delirium scale scores(Up to 1 hour after surgery.)
  • Number of patients who will develop postoperative nausea and vomiting.(Up to 2 hours after surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radwa Emad Eissa

lecturer of anesthesiology, surgical intensive care and pain medicine

Tanta University

研究点 (1)

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