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

Anesthesia Clinical Trial

— HYDRATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253052
• Other study ID #: HYDRATE
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Wuerzburg University Hospital
• Contact: Tobias E Haas, Dr.
• Phone: +49 931 201
• Email: haas_t1[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 decrease patient thirst and increase patient satisfaction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Aspiration
• Thirst; Due to Deprivation of Water

Intervention

Behavioral:
• Additional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
• 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.

Locations

Country	Name	City	State
Germany	Wuerzburg University Hospital	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thirst	At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)	Prior to induction of anaesthesia
Secondary	Total number of protocol deviations per group	Outcome assessment successfully blinded Real fluid fasting time is less than allocated fluid fasting time	From enrollment until last Follow-up is concluded at up to 48 hours post surgery
Secondary	Fluid fasting time	Actual fluid fasting time in hours	Prior to induction of anesthesia
Secondary	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.	2 hours after end of surgery
Secondary	CAM-ICU	Confusion Assessment Method for the Intensive Care Unit.	2 hours after end of surgery
Secondary	Headache	At any stage after your hospital admission have you had the following: Headache (No/ Yes, moderate/ Yes, severe)	Prior to induction of anesthesia and 2 hours after end of surgery
Secondary	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 anesthesiawill be reported.	5 minutes prior and 15 minutes after induction of anesthesia
Secondary	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.	5 minutes prior and 15 minutes after induction of anesthesia
Secondary	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.	5 minutes prior and 15 minutes after induction of anesthesia
Secondary	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.	5 minutes prior and 15 minutes after induction of anesthesia
Secondary	Vasopressor	Use of Vasopressors	Within 15 minutes after induction of anesthesia
Secondary	Blood glucose level	Blood glucose level	At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)
Secondary	Intravenous catheter placement	Number of attempts for placing a (first) peripheral intravenous catheter (only applicable if a peripheral intravenous catheter needs to be placed)	Between admission to the operation room and induction of anesthesia
Secondary	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.	2 hours after end of surgery
Secondary	Unplanned ICU/IMC	Unplanned intensive/intermediate care unit stay due to respiratory complications	From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
Secondary	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	From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery
Secondary	All cause mortality	Death within observation period	From end of surgery until last Follow-up is concluded at up to 48 hours post surgery