Anesthesia, Aspiration, Thirst; Due to Deprivation of Water
Conditions
Keywords
Surgery, Postoperative Nausea and Vomiting, Delirium, Dehydration, Satisfaction, Patient, Headache
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.
Interventions
BEHAVIORALAdditional pre-OP-visit
OP-schedule is closely monitored and patients will be visited to support and encourage them in drinking clear fluids.
BEHAVIORALLiberal fasting regime
Patients may drink up to 200 ml clear fluids between 2 h prior to the surgery and the call to operation room.
Sponsors
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| Vasopressor | Within 15 minutes after induction of anesthesia | Use of Vasopressors |
Countries
Germany
Outcome results
None listed