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

Not Applicable

Completed

• Conditions: Thirst; Due to Deprivation of Water; Anesthesia; Aspiration
• Interventions: Behavioral: Additional pre-OP-visit; Behavioral: Liberal fasting regime

• Registration Number: NCT06253052
• Lead Sponsor: Wuerzburg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-12
• Study Start: 2024-07-24
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instructed guideline adherence	Additional pre-OP-visit	Patients should not involuntarily fast fluids for longer than 2 h.
Experimental intervention	Liberal fasting regime	Patients should not involuntarily fast fluids for longer than 30 min.
Experimental intervention	Additional pre-OP-visit	Patients should not involuntarily fast fluids for longer than 30 min.

Primary Outcome Measures

Name	Time	Method
Thirst	Prior to induction of anaesthesia	At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)

Secondary Outcome Measures

Name	Time	Method
Total number of protocol deviations per group	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
Fluid fasting time	Prior to induction of anesthesia	Actual fluid fasting time in hours
RASS	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.
CAM-ICU	2 hours after end of surgery	Confusion Assessment Method for the Intensive Care Unit.
Headache	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)
Change of diastolic blood pressure on induction of anesthesia	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.
Change of mean arterial pressure on induction of anesthesia	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.
Vasopressor	Within 15 minutes after induction of anesthesia	Use of Vasopressors
Blood glucose level	At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)	Blood glucose level
Intravenous catheter placement	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)
Postoperative nausea and vomiting	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.
Unplanned ICU/IMC	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
Change of heart rate on induction of anesthesia	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.
Change of systolic blood pressure on induction of anesthesia	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.
Number of Participants with confirmed bronchopulmonary aspiration	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
All cause mortality	From end of surgery until last Follow-up is concluded at up to 48 hours post surgery	Death within observation period
Patient satisfaction	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.

Trial Locations

Locations (1)

Wuerzburg University Hospital; 🇩🇪 Würzburg, Bavaria, Germany