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

Wuerzburg University Hospital

Status: Completed

Conditions: Aspiration; Thirst; Due to Deprivation of Water; Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06253052

HYDRATE

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult patients (≥ 18 years)
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. Absolute indication for rapid sequence induction including but not limited to:

   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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 3 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

Patients should not involuntarily fast fluids for longer than 2 h.

Treatment:

Behavioral: Additional pre-OP-visit

Experimental intervention

Experimental group

Description:

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

Treatment:

Behavioral: Liberal fasting regime

Behavioral: Additional pre-OP-visit