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AnesthesiaHYDRATENCT06253052

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

A study testing Additional pre-OP-visit and Liberal fasting regime in people with Anesthesia and Thirst; Due to Deprivation of Water, run by Wuerzburg University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Additional pre-OP-visit and Liberal fasting regime
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteGermany
Study dates
24 Jul 2024to 4 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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:
Show all 17Show fewer
  • 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
  • Pregnancy
  • Expected need for postoperative mechanical ventilation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Wuerzburg University Hospital

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: A Pilot Study to Test Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients

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.

Being tested
Additional pre-OP-visit, Liberal fasting regime
Keywords
Surgery, Postoperative Nausea and Vomiting, Delirium, Dehydration, Satisfaction, Patient, Headache
Medical subject headings
Postoperative Nausea and Vomiting, Delirium, Dehydration, Patient Satisfaction, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional pre-OP-visitBehavioural

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

  • Liberal fasting regimeBehavioural

    Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room.

Study groups in NCT06253052
Study groupRoleWhat they receive
Usual careNo interventionFasting instructions as given by anaesthesiologist according to national guidelines (6 h solid meal and thick liquids, 2 h clear fluids).
Instructed guideline adherenceActive comparatorPatients should not involuntarily fast fluids for longer than 2 h.
Receives: Behavioral: Additional pre-OP-visit
Experimental interventionExperimentalPatients should not involuntarily fast fluids for longer than 30 min.
Receives: Behavioral: Additional pre-OP-visit; Behavioral: Liberal fasting regime

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thirst

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

    Measured: Prior to induction of anaesthesia

Secondary outcomes (17)

  1. Total number of protocol deviations per group

    Outcome assessment successfully blinded Real fluid fasting time is less than allocated fluid fasting time

    Measured: From enrollment until last Follow-up is concluded at up to 48 hours post surgery

  2. Fluid fasting time

    Actual fluid fasting time in hours

    Measured: Prior to induction of anesthesia

  3. 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.

    Measured: 2 hours after end of surgery

  4. CAM-ICU

    Confusion Assessment Method for the Intensive Care Unit.

    Measured: 2 hours after end of surgery

  5. Headache

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

    Measured: Prior to induction of anesthesia and 2 hours after end of surgery

  6. 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.

    Measured: 5 minutes prior and 15 minutes after induction of anesthesia

  7. 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.

    Measured: 5 minutes prior and 15 minutes after induction of anesthesia

  8. 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.

    Measured: 5 minutes prior and 15 minutes after induction of anesthesia

  9. 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.

    Measured: 5 minutes prior and 15 minutes after induction of anesthesia

  10. Vasopressor

    Use of Vasopressors

    Measured: Within 15 minutes after induction of anesthesia

  11. Blood glucose level

    Blood glucose level

    Measured: At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)

  12. Intravenous catheter placement

    Number of attempts for placing a (first) peripheral intravenous catheter (only applicable if a peripheral intravenous catheter needs to be placed)

    Measured: Between admission to the operation room and induction of anesthesia

  13. 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.

    Measured: 2 hours after end of surgery

  14. Unplanned ICU/IMC

    Unplanned intensive/intermediate care unit stay due to respiratory complications

    Measured: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery

  15. 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

    Measured: From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery

  16. All cause mortality

    Death within observation period

    Measured: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery

  17. 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.

    Measured: 2 hours after end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start24 Jul 2024
  3. Primary completion4 Nov 2024
  4. Study completion4 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253052
Sponsor's protocol ID
HYDRATE
Acronym
HYDRATE
Status last verified
May 2025
First submitted
5 Jan 2024
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41257406

Questions about this trial

What is this clinical trial studying?

A study testing Additional pre-OP-visit and Liberal fasting regime in people with Anesthesia and Thirst; Due to Deprivation of Water, run by Wuerzburg University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thirst (time frame: Prior to induction of anaesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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