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Completed

NCT Number: NCT06253052

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.

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Key information

Conditions

Anesthesia Aspiration Behavior Confusion Dehydration Delirium Headache Health Behavior Mental Disorders Metabolic Diseases Nausea Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Thirst; Due to Deprivation of Water Treatment Adherence and Compliance Vomiting Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuerzburg University Hospital

Würzburg, Bavaria, 97080, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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
  • Pregnancy
  • Expected need for postoperative mechanical ventilation

Treatment and study plan

Additional pre-OP-visit

Behavioral

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

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.

Primary outcomes

  1. Thirst

    Time frame: Prior to induction of anaesthesia

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

Secondary outcomes

  1. Total number of protocol deviations per group

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

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

  2. Fluid fasting time

    Time frame: Prior to induction of anesthesia

    Actual fluid fasting time in hours

  3. RASS

    Time frame: 2 hours after end of surgery

    Richmond Agitation Sedation Scale. A scale from -5 to +4 is used. Negative values indicate a sedated state. Positive values indicate an agitated state.

  4. CAM-ICU

    Time frame: 2 hours after end of surgery

    Confusion Assessment Method for the Intensive Care Unit.

  5. Headache

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

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

  6. Change of heart rate on induction of anesthesia

    Time frame: 5 minutes prior and 15 minutes after induction of anesthesia

    The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.

  7. Change of systolic blood pressure on induction of anesthesia

    Time frame: 5 minutes prior and 15 minutes after induction of anesthesia

    The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.

  8. Change of diastolic blood pressure on induction of anesthesia

    Time frame: 5 minutes prior and 15 minutes after induction of anesthesia

    The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.

  9. Change of mean arterial pressure on induction of anesthesia

    Time frame: 5 minutes prior and 15 minutes after induction of anesthesia

    The difference between the highest value before induction of anesthesia and the lowest value after induction of anesthesia will be reported.

  10. Vasopressor

    Time frame: Within 15 minutes after induction of anesthesia

    Use of Vasopressors

  11. Blood glucose level

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

    Blood glucose level

  12. Intravenous catheter placement

    Time frame: Between admission to the operation room and induction of anesthesia

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

  13. Postoperative nausea and vomiting

    Time frame: 2 hours after end of surgery

    Postoperative nausea and vomiting is a composite endpoint of the following dimensions: Vomiting, retching, nausea, and/or use of rescue medication.

  14. Unplanned ICU/IMC

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

    Unplanned intensive/intermediate care unit stay due to respiratory complications

  15. Number of Participants with confirmed bronchopulmonary aspiration

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

    If relevant bronchopulmonary aspiration is suspected, it needs to be confirmed by bronchoscopy or radiology imaging up to 48 hours after anaesthesia procedure

  16. All cause mortality

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

    Death within observation period

  17. Patient satisfaction

    Time frame: 2 hours after end of surgery

    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.

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: HYDRATE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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