NCT06253052已完成不适用
A Pilot Study to Test Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Thirst
研究概览
简要总结
The purpose of this study is to show if - compared to standard practice - allowing adults undergoing surgical procedures under anaesthesia care to drink clear fluids up to a volume of 200 ml between 2 h prior to the operation and the call to operation room (approximately 30 min prior to anaesthesia induction) will decrease patient thirst and increase patient satisfaction.
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
- Single (Outcomes Assessor)
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
- •Adult patients (≥ 18 years)
- •American Society of Anesthesiologists (ASA) physical status classification I-III
- •Undergoing surgical procedure under anaesthesia care: general anaesthesia, regional anaesthesia, combined anaesthesia or monitored anaesthesia care.
- •The proportion of Patients undergoing general or combined anaesthesia is aimed to exceed 75%
排除标准
- •Absolute indication for rapid sequence induction including but not limited to:
- •Bowel obstruction including ileus
- •Stricture and oesophageal disorders including achalasia
- •Recent polytrauma or trauma of the upper gastrointestinal tract
- •Acute abdomen/peritonitis including active gastrointestinal bleeding
- •Relative indication for (modified) rapid sequence induction includes, but is not limited to:
- •Symptomatic gastroesophageal reflux disease, independent of food intake and persistent under medical treatment (PPI)
- •Hiatus hernia or upside down stomach
- •Upper gastrointestinal tumour
- •History of upper gastrointestinal surgery (oesophageal, gastric, duodenum, pancreatic)
- •Medically confirmed gastroparesis
- •Severe obesity, defined as body mass index ≥ 40 kg/m2
- •Renal replacement therapy
- •Fluid restriction therapy
- •Expected need for postoperative mechanical ventilation
研究组 & 干预措施
Usual care
No Intervention
Fasting instructions as given by anaesthesiologist according to national guidelines (6 h solid meal and thick liquids, 2 h clear fluids).
Instructed guideline adherence
Active Comparator
Patients should not involuntarily fast fluids for longer than 2 h.
干预措施: Additional pre-OP-visit (Behavioral)
Experimental intervention
Experimental
Patients should not involuntarily fast fluids for longer than 30 min.
干预措施: Additional pre-OP-visit (Behavioral)
Experimental intervention
Experimental
Patients should not involuntarily fast fluids for longer than 30 min.
干预措施: Liberal fasting regime (Behavioral)
结局指标
主要结局
Thirst
时间窗: Prior to induction of anaesthesia
At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)
次要结局
- Vasopressor(Within 15 minutes after induction of anesthesia)
- Blood glucose level(At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted))
- Total number of protocol deviations per group(From enrollment until last Follow-up is concluded at up to 48 hours post surgery)
- Fluid fasting time(Prior to induction of anesthesia)
- RASS(2 hours after end of surgery)
- CAM-ICU(2 hours after end of surgery)
- Headache(Prior to induction of anesthesia and 2 hours after end of surgery)
- Change of diastolic blood pressure on induction of anesthesia(5 minutes prior and 15 minutes after induction of anesthesia)
- Change of mean arterial pressure on induction of anesthesia(5 minutes prior and 15 minutes after induction of anesthesia)
- Intravenous catheter placement(Between admission to the operation room and induction of anesthesia)
- Postoperative nausea and vomiting(2 hours after end of surgery)
- Unplanned ICU/IMC(From end of surgery until last Follow-up is concluded at up to 48 hours post surgery)
- Change of heart rate on induction of anesthesia(5 minutes prior and 15 minutes after induction of anesthesia)
- Change of systolic blood pressure on induction of anesthesia(5 minutes prior and 15 minutes after induction of anesthesia)
- Number of Participants with confirmed bronchopulmonary aspiration(From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery)
- All cause mortality(From end of surgery until last Follow-up is concluded at up to 48 hours post surgery)
- Patient satisfaction(2 hours after end of surgery)
研究者
研究点 (1)
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