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临床试验/NCT07082894
NCT07082894招募中不适用

The Effect of Preoperative Oral Magnesium on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Double Blind Randomized Placebo Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月25日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
120
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 oral magnesium 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. Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness. Regarding its use as a preventive measure against emergence agitation in children, only intraoperative intravenous route was studied and the results of previous reports were inconsistent. Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.

In this novel study, the investigators will use magnesium via oral route before surgery as they hypothesize that the pre-emptive administration of the drug may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects 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
Double (Participant, Outcomes Assessor)

盲法说明

double blinded

入排标准

年龄范围
4 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
  • Allergy to magnesium

研究组 & 干预措施

Magnesium group

Experimental

cases will receive preoperative oral magnesium dose of 120 mg at one hour before surgery

干预措施: Magnesium (Drug)

Control group

Placebo Comparator

cases will receive oral lemon juice at one hour 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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