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

NCT ID: NCT06253052

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2024-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Thirst; Due to Deprivation of Water Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Fasting instructions as given by anaesthesiologist according to national guidelines (6 h solid meal and thick liquids, 2 h clear fluids).

Group Type NO_INTERVENTION

No interventions assigned to this group

Instructed guideline adherence

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

Group Type ACTIVE_COMPARATOR

Additional pre-OP-visit

Intervention Type BEHAVIORAL

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

Experimental intervention

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

Group Type EXPERIMENTAL

Additional pre-OP-visit

Intervention Type BEHAVIORAL

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

Liberal fasting regime

Intervention Type BEHAVIORAL

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

Interventions

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Additional pre-OP-visit

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

Intervention Type BEHAVIORAL

Liberal fasting regime

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Meybohm, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

Tobias E Haas, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany

Locations

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Wuerzburg University Hospital

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HYDRATE

Identifier Type: -

Identifier Source: org_study_id

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