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

Wuerzburg University Hospital174 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

174

Conditions

Anesthesia Thirst; Due to Deprivation of Water Aspiration

Interventions

Additional pre-OP-visitBEHAVIORAL

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

Liberal fasting regimeBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wuerzburg University Hospital

Würzburg, Bavaria, Germany

Outcomes

Primary Outcomes

Thirst

At any stage after your hospital admission have you had the following: Thirst (No/ Yes, moderate/ Yes, severe)

Time frame: Prior to induction of anaesthesia

Secondary Outcomes

Total number of protocol deviations per group

Outcome assessment successfully blinded Real fluid fasting time is less than allocated fluid fasting time

Time frame: From enrollment until last Follow-up is concluded at up to 48 hours post surgery

Fluid fasting time

Actual fluid fasting time in hours

Time frame: Prior to induction of anesthesia

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.

Time frame: 2 hours after end of surgery

CAM-ICU

Confusion Assessment Method for the Intensive Care Unit.

Time frame: 2 hours after end of surgery

Headache

At any stage after your hospital admission have you had the following: Headache (No/ Yes, moderate/ Yes, severe)

Time frame: Prior to induction of anesthesia and 2 hours after end of surgery

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 anesthesia will be reported.

Time frame: 5 minutes prior and 15 minutes after induction of anesthesia

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.