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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Experimental intervention | Experimental | Patients should not involuntarily fast fluids for longer than 30 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional pre-OP-visit | Behavioral | OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thirst | At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe) | Prior to induction of anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of protocol deviations per group | Outcome assessment successfully blinded Real fluid fasting time is less than allocated fluid fasting time | From enrollment until last Follow-up is concluded at up to 48 hours post surgery |
| Fluid fasting time |
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Inclusion Criteria:
The proportion of Patients undergoing general or combined anaesthesia is aimed to exceed 75%
Exclusion Criteria:
Absolute indication for rapid sequence induction including but not limited to:
Relative indication for (modified) rapid sequence induction includes, but is not limited to:
Dysphagia
Renal replacement therapy
Fluid restriction therapy
Pregnancy
Expected need for postoperative mechanical ventilation
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Meybohm, Prof. Dr. | University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany | Study Director |
| Tobias E Haas, Dr. | University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuerzburg University Hospital | Würzburg | Bavaria | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41257406 | Derived | Haas TE, Kranke P, Stegemann MN, Helmer P, Schmid B, Diehl FM, Heuschmann PU, Rucker V, Seitz AK, Diessner J, Heintel T, Saller T, Ruggeberg A, Kronert S, von Keitz J, Meybohm P. Benefits in adults allowed to drink clear liquids before anaesthesia until called to the operating room: A randomised pilot study. Eur J Anaesthesiol. 2026 Mar 1;43(3):207-216. doi: 10.1097/EJA.0000000000002309. Epub 2025 Nov 18. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2024 | Aug 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D003693 | Delirium |
| D003681 | Dehydration |
| D017060 | Patient Satisfaction |
| D006261 | Headache |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| Liberal fasting regime | Behavioral | Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room. |
|
Actual fluid fasting time in hours |
| Prior to induction of anesthesia |
| RASS | Richmond Agitation Sedation Scale. A scale from -5 to +4 is used. Negative values indicate a sedated state. Positive values indicate an agitated state. | 2 hours after end of surgery |
| CAM-ICU | Confusion Assessment Method for the Intensive Care Unit. | 2 hours after end of surgery |
| Headache | At any stage after your hospital admission have you had the following: Headache (No/ Yes, moderate/ Yes, severe) | Prior to induction of anesthesia and 2 hours after end of surgery |
| Change of heart rate on induction of anesthesia | The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported. | 5 minutes prior and 15 minutes after induction of anesthesia |
| Change of systolic blood pressure on induction of anesthesia | The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported. | 5 minutes prior and 15 minutes after induction of anesthesia |
| Change of diastolic blood pressure on induction of anesthesia | The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported. | 5 minutes prior and 15 minutes after induction of anesthesia |
| Change of mean arterial pressure on induction of anesthesia | The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported. | 5 minutes prior and 15 minutes after induction of anesthesia |
| Vasopressor | Use of Vasopressors | Within 15 minutes after induction of anesthesia |
| Blood glucose level | Blood glucose level | At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted) |
| Intravenous catheter placement | Number of attempts for placing a (first) peripheral intravenous catheter (only applicable if a peripheral intravenous catheter needs to be placed) | Between admission to the operation room and induction of anesthesia |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting is a composite endpoint of the following dimensions: Vomiting, retching, nausea, and/or use of rescue medication. | 2 hours after end of surgery |
| Unplanned ICU/IMC | Unplanned intensive/intermediate care unit stay due to respiratory complications | From end of surgery until last Follow-up is concluded at up to 48 hours post surgery |
| Number of Participants with confirmed bronchopulmonary aspiration | If relevant bronchopulmonary aspiration is suspected, it needs to be confirmed by bronchoscopy or radiology imaging up to 48 hours after anaesthesia procedure | From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery |
| All cause mortality | Death within observation period | From end of surgery until last Follow-up is concluded at up to 48 hours post surgery |
| Patient satisfaction | Patient satisfaction, operationalized using the Bauer Satisfaction Questionnaire, includes 10 ordinal items with 3 levels (where higher values indicate unfavourable outcomes), 5 items on a Likert scale with 4 levels (where lower values indicate unfavourable outcomes), and one binary item. | 2 hours after end of surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010146 | Pain |