Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study
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
- 否
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
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
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
Radwa Emad Eissa
lecturer of anesthesiology, surgical intensive care and pain medicine
Tanta University
