Study the Possible Effects of Intraoperative Intravenous Magnesium Sulphate Infusion on the Incidence of Sevoflurane Induced Emergence Agitation in Children Undergoing Adenotonsillectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change from baseline of sevoflurane induced emergence agitation(EA) at 2 hours postoperative by using Pediatric Anesthesia Emergence Delirium (PEAD) score
研究概览
简要总结
Rationale:
Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis, in which rapid recovery with safe airway after extubation is crucial. Sevoflurane is considered the inhaled anesthetic of choice in such procedures, however it has been reported that emergence agitation (EA) is a frequent complication in 30-80% of children receiving sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the incidence of EA in children was not adequately investigated.
Objective:
To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4) infusion on the incidence of sevoflurane-induced EA in children undergoing adenotonsillectomy.
Study population and sample size:
Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance difference of 40% in the incidence of agitation between two groups, with a power of 80% and alpha error of 5%.
Study design:
A double blind, randomized, placebo controlled study.
Method:
In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end of surgery. Post operative emergence agitation will be assessed by using the Pediatric Anesthesia Emergence Delirium scale.
Possible risks:
Drug side effects such as facial warmth, flushing, dry mouth, and malaise.
Outcome parameters:
The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative complications
Statistical analysis plan:
Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as appropriate. The possible relationship between EA and pain scores will be evaluated with the use of Spearman's rank correlation coefficient
Time plan:
6-9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included in the study.
排除标准
- •The study will exclude children with behavioral changes, physical developmental delay and children on treatment with sedative or anticonvulsant. Also children with pre-existing renal disease or cardiovascular diseases will be excluded.
研究组 & 干预措施
Magnesium sulphate
Magnesium sulphate (MgSO4) 10% solution is going to be used, an initial MgSO4 bolus dose 30mg/kg (i.e. 0.3mL/kg) will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous infusion of 10 mg/kg/hr (i.e. 0.1 ml/kg/h). Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
干预措施: Magnesium Sulfate (Drug)
normal saline
normal saline (NaCl 9%) is going to be used, an initial normal saline bolus dose 0.3ml/kg will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous normal saline infusion of 0.1 ml/kg/h. Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
干预措施: normal saline (Drug)
结局指标
主要结局
change from baseline of sevoflurane induced emergence agitation(EA) at 2 hours postoperative by using Pediatric Anesthesia Emergence Delirium (PEAD) score
时间窗: on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively
次要结局
- postoperative pain which is going to be assessed by the well established behavior pain scale "Children's Hospital Eastern Ontario Scale" (CHEOPS)(on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively)
研究者
Abeer Ahmed
lecturer of anesthesia, faculty of medicine, cairo university
Cairo University