Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Modified-Yale Preoperative Anxiety Scale
研究概览
简要总结
Preoperative fasting is intended to lower the amount of gastric contents in order to decrease the incidence of aspiration associated with endotracheal intubation. However, recent studies show that longer fasting time does not reduce aspiration associated complications. Especially in pediatric patients, long fasting time increases patients' unpleasantness and therefore increases postoperative recovery quality. It also induces hypoglycemia. In many studies, ingesting clear liquids 2 hours up to general anesthesia decreases gastric contents and therefore the incidence of aspiration pneumonia, postoperative nausea and vomiting. Therefore anesthesiologist associations in the US and Europe recommend to drink small amount of clear liquid (water) up to 2 hours before the surgery.
Nuss bar operation, or repair surgery of pectus excavatum is mostly done in pediatric patients. The procedure itself is very painful, requiring paramount amount of analgesics. Use of opioid analgesics increases postoperative nausea and vomiting.
In this study, our aim is to evaluate preoperative fasting time and how preoperative supplement of clear liquid affects the quality of recovery postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients from age 3 to 6
- •Undergoing repair surgery for pectus excavatum
- •American Society of Anesthesiologists class I to III
排除标准
- •Any diseases or past surgical procedures involving gastrointestinal tract
- •Past history of psychiatric diseases
- •On chronic analgesic medication
- •Patients or Patients' caregivers do not agree to attend the study
研究组 & 干预措施
8 hours fasting group
Routine preoperative fasting group undergoes 8 hours of fasting before the operation.
Clear liquid group
30 pediatric patients drink 3ml/kg 1 hour before the surgery. Although "clear liquid" suggests any drinks that do not contain any solid ingredients, but in this study we define "clear liquid" as water.
干预措施: New Care No Nil Per Os (Dietary Supplement)
Carbohydrate containing liquid group
Other 30 pediatric patients drink 3ml/kg of carbohydrate containing fluid 1 hour before the surgery. The product name we have is "NoNPO" from NewCare (South Korean company). This fluid does not contain any solid ingredients, so consuming the fluid does not exceed Nil per Os time needed before the surgery.
干预措施: New Care No Nil Per Os (Dietary Supplement)
结局指标
主要结局
Modified-Yale Preoperative Anxiety Scale
时间窗: Preoperatively at the surgery waiting room
MyPas scale measures 4 categories: Activity, Vocalizations, Emotional Expressivity and State of Apprent Arousal. Each category has 1 to 4 scales for activity, emotional expresivity and state of apprent arousal, and 1 to 6 for vocalizations, that each describes the child's anxiety status. The observer collects total score ranging from 4 to 18.
Pain Score
时间窗: 30 minutes postoperatively at postoperative discharge unit
Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.
Emergence delirium
时间窗: 60 Minutes postoperatively
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Emergence delirium
时间窗: 5 Minutes postoperatively at postoperative discharge unit
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Emergence delirium
时间窗: 10 Minutes postoperatively at postoperative discharge unit
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Emergence delirium
时间窗: 15 Minutes postoperatively at postoperative discharge unit
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Emergence delirium
时间窗: 30 Minutes postoperatively at postoperative discharge unit
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Emergence delirium
时间窗: 45 Minutes postoperatively at postoperative discharge unit
"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.
Pain Score
时间窗: 5 minutes postoperatively at postoperative discharge unit
Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.
Pain Score
时间窗: 10 minutes postoperatively at postoperative discharge unit
Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.
Pain Score
时间窗: 15 minutes postoperatively at postoperative discharge unit
Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.
次要结局
- Other pro re nata analgesics used, amount and type(Between 24~48 hours postoperatively)
- Any postoperative side effects(Between 24~48 hours postoperatively)
- Pain scores(Between 24~48 hours postoperatively)
- Any postoperative side effects(Between 1~6 hours postoperatively)
- Any postoperative side effects(Between 12~24 hours postoperatively)
- Pain scores(Between 1~6 hours postoperatively)
- Pain scores(Between 12~24 hours postoperatively)
- Other pro re nata analgesics used, amount and type(Between 1~6 hours postoperatively)
- Other pro re nata analgesics used, amount and type(Between 12~24 hours postoperatively)
研究者
Jung Min Koo
Principal Investigator
Seoul St. Mary's Hospital