Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients

NCT06253052 | Completed

• 1 other identifier: HYDRATE
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Thirst; Due to Deprivation of Water; Aspiration

Keywords

Surgery; Postoperative Nausea and Vomiting; Delirium; Dehydration; Satisfaction, Patient; Headache

Outcome Measures

Primary Outcomes (1)

• Thirst

  At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)

  Prior to induction of anaesthesia

Secondary Outcomes (17)

• 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

Study Arms (3)

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.

Behavioral: Additional pre-OP-visit

Experimental intervention

EXPERIMENTAL

Patients should not involuntarily fast fluids for longer than 30 min.

Behavioral: Additional pre-OP-visit; Behavioral: Liberal fasting regime

Interventions

Additional pre-OP-visit BEHAVIORAL

OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.

Experimental intervention; Instructed guideline adherence

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.

Experimental intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• Dysphagia
• Renal replacement therapy
• Fluid restriction therapy

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Wuerzburg University Hospital

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (1)

• 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. 2025 Nov 19. doi: 10.1097/EJA.0000000000002309. Online ahead of print.

  PMID: 41257406 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Delirium; Dehydration; Patient Satisfaction; Headache

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Pain

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 12, 2024
• Study Start: July 24, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

DE (1)