Anesthesia, Aspiration; Gastric Contents, Anesthesia, Fasting Before Operation, Monitored Anesthesia Care, Procedure, Sedation, Surgery, Surgery, Day, Surgery Scheduled
Conditions
Keywords
preoperative fasting, perioperative pulmonary aspiration, perioperative complications, postoperative nausea and vomiting, perioperative hypoglycemia, perioperative hyperglycemia, perioperative hypotension, myocardial injury after noncardiac surgery, perioperative acute kidney injury, clear liquid fasting
Brief summary
Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. The research team hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology. The investigators will also test for an association between the duration of preoperative fasting and the risk of perioperative pulmonary aspiration. Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.
Interventions
OTHERPreoperative fasting
This cohort study assesses the duration of preoperative fasting and its clinical effects
Sponsors
Massachusetts General Hospital
Anesthesia Patient Safety Foundation (APSF)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)
Exclusion criteria
* Not receiving anesthesia care * Lack of medical record data in Epic electronic medical record system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | 12 hours postoperatively | The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h postoperatively. |
| Intraoperative hypotension | Intraoperative period. | The co-primary outcome of intraoperative hypotension is defined as an area under the curve of intraoperative mean arterial pressure \<65 mm Hg. |
| Perioperative acute kidney injury (AKI) | Postoperative days 0 to 7 | The co-primary outcome of perioperative AKI is defined as stage 1 or higher, based on Kidney Disease Improving Global Outcomes criteria (creatinine rise ≥ 0.3 mg/dl within 48 h or ≥ 1.5 times baseline) from postoperative day (POD) 0 until POD 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of prolonged preoperative fasting for clear liquids | 48 hours preoperatively | Incidence of prolonged preoperative fasting for clear liquids is defined as fasting that exceeds the American Society of Anesthesiologists-recommended duration by a factor of 2 or more (≥ 4 hours). |
| Severity of prolonged clear liquid fasting | 48 hours preoperatively | Severity of prolonged clear liquid fasting is defined as the frequency of fasting duration that exceeds the currently recommended by 2x, 4x, 6x, etc. |
| Perioperative hypoglycemia | 12 hours preoperatively to 24 hours postoperatively | Perioperative hypoglycemia: any blood glucose concentration \< 70 mg/dL from 12 h before to 24 h after the procedure |
| Perioperative hyperglycemia | 12 hours preoperatively to 24 hours postoperatively | Perioperative hyperglycemia is defined as any blood glucose concentration \> 140 mg/dL from 12 h before to 24 h after the procedure. |
| Perioperative AKI stage 2 or higher. | Postoperative days 0 to 7 | Perioperative AKI stage 2 or higher is defined as creatinine at least twice the baseline level between POD0 to POD7. |
| Myocardial injury after noncardiac surgery (MINS) | Postoperative day 0 to 3 | Myocardial injury after noncardiac surgery is defined as increased cardiac troponin I above the 99th percentile within 3 days after surgery. |
Countries
United States
Contacts
CONTACTAlexander Nagrebetsky, MD, MSc
Outcome results
None listed