Clinical trial NCT06253052: Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
Official title: A Pilot Study to Test Benefits of Drinking Clear Fluids Until Called to the Operating Room in Adult Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Thirst; Due to Deprivation of Water
Aspiration
Keywords: Surgery
Postoperative Nausea and Vomiting
Delirium
Dehydration
Satisfaction, Patient
Headache
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Thirst
timeFrame: Prior to induction of anaesthesia
Secondary outcomes:
measure: Total number of protocol deviations per group
timeFrame: From enrollment until last Follow-up is concluded at up to 48 hours post surgery
measure: Fluid fasting time
timeFrame: Prior to induction of anesthesia
measure: RASS
timeFrame: 2 hours after end of surgery
measure: CAM-ICU
timeFrame: 2 hours after end of surgery
measure: Headache
timeFrame: Prior to induction of anesthesia and 2 hours after end of surgery
measure: Change of heart rate on induction of anesthesia
timeFrame: 5 minutes prior and 15 minutes after induction of anesthesia
measure: Change of systolic blood pressure on induction of anesthesia
timeFrame: 5 minutes prior and 15 minutes after induction of anesthesia
measure: Change of diastolic blood pressure on induction of anesthesia
timeFrame: 5 minutes prior and 15 minutes after induction of anesthesia
measure: Change of mean arterial pressure on induction of anesthesia
timeFrame: 5 minutes prior and 15 minutes after induction of anesthesia
measure: Vasopressor
timeFrame: Within 15 minutes after induction of anesthesia
measure: Blood glucose level
timeFrame: At induction of anesthesia (Values assessed within 15 minutes prior and 15 minutes after induction of anesthesia will be accepted)
measure: Intravenous catheter placement
timeFrame: Between admission to the operation room and induction of anesthesia
measure: Postoperative nausea and vomiting
timeFrame: 2 hours after end of surgery
measure: Unplanned ICU/IMC
timeFrame: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
measure: Number of Participants with confirmed bronchopulmonary aspiration
timeFrame: From induction of anesthesia until last Follow-up is concluded at up to 48 hours post surgery
measure: All cause mortality
timeFrame: From end of surgery until last Follow-up is concluded at up to 48 hours post surgery
measure: Patient satisfaction
timeFrame: 2 hours after end of surgery
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Wuerzburg University Hospital
state: Bavaria
Study officials:
affiliation: University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
name: Patrick Meybohm, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
name: Tobias E Haas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: