Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
NCT ID: NCT06253052
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2024-07-24
2024-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual care
Fasting instructions as given by anaesthesiologist according to national guidelines (6 h solid meal and thick liquids, 2 h clear fluids).
No interventions assigned to this group
Instructed guideline adherence
Patients should not involuntarily fast fluids for longer than 2 h.
Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
Experimental intervention
Patients should not involuntarily fast fluids for longer than 30 min.
Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
Liberal fasting regime
Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room.
Interventions
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Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
Liberal fasting regime
Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room.
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists (ASA) physical status classification I-III
3. 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%
Exclusion Criteria
1. Bowel obstruction including ileus
2. Stricture and oesophageal disorders including achalasia
3. Recent polytrauma or trauma of the upper gastrointestinal tract
4. Acute abdomen/peritonitis including active gastrointestinal bleeding
2. Relative indication for (modified) rapid sequence induction includes, but is not limited to:
1. Symptomatic gastroesophageal reflux disease, independent of food intake and persistent under medical treatment (PPI)
2. Hiatus hernia or upside down stomach
3. Upper gastrointestinal tumour
4. History of upper gastrointestinal surgery (oesophageal, gastric, duodenum, pancreatic)
5. Medically confirmed gastroparesis
6. Severe obesity, defined as body mass index ≥ 40 kg/m2
3. Dysphagia
4. Renal replacement therapy
5. Fluid restriction therapy
6. Pregnancy
7. Expected need for postoperative mechanical ventilation
18 Years
ALL
Yes
Sponsors
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Wuerzburg University Hospital
OTHER
Responsible Party
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Principal Investigators
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Patrick Meybohm, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Tobias E Haas, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Locations
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Wuerzburg University Hospital
Würzburg, Bavaria, Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HYDRATE
Identifier Type: -
Identifier Source: org_study_id
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