The Effects of Preoperative Oral Carbohydrate-electrolyte Solution Compared to Standard Clear Fluid on Metabolic Responses, Preoperative Anxiety and Postoperative Complications in Paediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
The aim of this study is to evaluate the effects of oral administration of carbohydrate-electrolyte-containing fluid, compared to standard clear fluid during preoperative fasting on metabolic responses, preoperative anxiety and postoperative complications in paediatric patients. Subjects will be randomly allocated into 2 groups: the intervention group will receive carbohydrate- electrolyte fluid whilst the control group will receive clear fluid. Both groups will receive 50 ml/kg of their designated fluid one day prior to surgery, and are allowed to consume the fluid gradually until 1 hour before the induction of anaesthesia. Prior to induction, preoperative anxiety will be assessed. Metabolic responses will be assessed through the degree of insulin resistance (using the Homeostatic Model Assessment for Insulin Resistance - HOMA-IR) and inflammatory cytokine (Interleukin-6) level. The metabolic responses will be evaluated after the induction of anaesthesia and 24 hours following the surgery. Preoperative anxiety will be assessed before the surgery using the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF). Immediate post operative complications such as post operative nausea and vomiting (PONV), emergence delirium and postoperative pain will be assessed in the recovery room.
详细描述
The aim of this study is to evaluate the effects of oral administration of carbohydrate-electrolyte-containing fluid, compared to standard clear fluid during preoperative fasting on metabolic responses, preoperative anxiety and postoperative complications in paediatric patients. Metabolic responses will be assessed through the degree of insulin resistance (using the Homeostatic Model Assessment for Insulin Resistance - HOMA-IR) and inflammatory cytokine (Interleukin-6) level. The metabolic responses will be evaluated after the induction of anaesthesia and 24 hours following the surgery. Preoperative anxiety will be assessed before the surgery using the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF). Immediate post operative complications such as post operative nausea and vomiting (PONV), emergence delirium and postoperative pain will be assessed in the recovery room. This study is a single-blinded randomised controlled trial. Subjects will be randomly allocated into 2 groups: the intervention group will receive carbohydrate-electrolyte fluid whereas the control group will receive clear fluid. Both groups will receive 50 ml/kg of their designated fluid one day prior to surgery, and are allowed to consume the fluid gradually since the fluid is given (approximately 12 hours before the surgery) until 1 hour before induction of anaesthesia. The fluid used in this study will be prepared by the Pharmacy Department, independent from the research team, in which the randomization and which fluid given to patients remain concealed from the primary research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 1 month - 12 years old
- •Patients with physical status according to American Society of Anesthesiologists (ASA) 1 or 2
- •Patients undergoing surgery with general anesthesia with or without regional anesthesia
- •Has a relatively good enteral tolerability
排除标准
- •Patients with endocrine abnormalities
- •Patients requiring Pediatric intensive care unit (PICU) for post operative care and is likely to remain intubated following the end of the surgery
- •Patients who receive antiemetic therapy within 24 hours before the surgery
- •Patients undergoing cardiac surgery or neurosurgery
结局指标
主要结局
Insulin resistance
时间窗: 24 hours
Insulin resistance will be evaluated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), which is a model to estimate insulin sensitivity based on the ratio of insulin and blood glucose. The calculation of the HOMA-IR model uses the formula : HOMA-IR = insulin level (microIU/ml) x blood glucose level (mmol/L) / 22.5 Insulin resistance will be evaluated after the induction of anesthesia, and 24 hours following the operation. Since HOMA-IR is a ratio that requires insulin and blood glucose level, the insulin level (microIU/ml) and the blood glucose level (mmol/L) will also be evaluated after the induction, and 24 hours following the operation. A higher HOMA-IR ratio represents an increased level of insulin resistance.
Interleukin-6
时间窗: 24 hours
The level of interleukin-6 (pg/dl) in this study is evaluated to reflect the degree of body response to surgical trauma. It will be measured after the induction of anesthesia, and 24 hours after surgery. A higher interleukin-6 level indicates a higher inflammatory reaction following surgical trauma.
次要结局
- Emergence Delirium(1 hour)
- Post operative nausea and vomiting(1 hour)
- Postoperative pain(1 hour)
- Preoperative anxiety(1 hour)
研究者
Andi Ade Wijaya Ramlan
Principle Investigator
Indonesia University