Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)
研究概览
简要总结
In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >= 18 yrs
- •undergoing upper endoscopy procedure under general anesthesia without emergency
- •informed written consent
排除标准
- •emergency
- •might impair gastrointestinal motility (intestinal obstruction, stenosis)
- •diseases of the central and peripheral nervous system or neuromuscular diseases
- •drug-induced gastric emptying disorders
- •pregnancy
- •ionic disorders (hyponatremia<125mmol/l ; hypokalemia<3,5mmol/l
- •hemodynamic disorders (systolic arterial pressure <100mmHg)
- •unstable diabetes (glycemia>2,5g/l) ± insulin- dependent diabetes ± diabetic gastroparesis
- •the potential for difficult airway management
- •understanding of the information
- •patient with bad prognosis
研究组 & 干预措施
No intervention
Group overnight fasting
Group drink
Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia)
干预措施: group drink (Procedure)
结局指标
主要结局
percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)
时间窗: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia.
次要结局
- quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)(The participants will be followed for the duration of hospital stay, an expected average of one day.)
- gastric residual volume (ml)(The participants will be followed for the duration of hospital stay, an expected average of one day.)
- discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia(at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.)
- handgrip strength assessed by dynamometer just before anaesthesia(at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.)
- amount of propofol (mg)(The participants will be followed for the duration of hospital stay, an expected average of one day.)
- gastric acidity (pH)(The participants will be followed for the duration of hospital stay, an expected average of one day.)
- occurrence of vomiting(The participants will be followed for the duration of hospital stay, an expected average of one day.)
