The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative fasting.
- Who it may be relevant to
- Registry conditions: Anesthesia, Sedation, Monitored Anesthesia Care, Procedure. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Million Anesthesia Cases Study (MACS) - Retrospective and Prospective Characterization of Perioperative Fasting Practices and Their Effects on Clinical Outcomes
Overview
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
- Other Preoperative fasting
This cohort study assesses the duration of preoperative fasting and its clinical effects
Primary outcome measures
- Postoperative nausea and vomiting (PONV) [Time frame: 12 hours postoperatively]
- Intraoperative hypotension [Time frame: Intraoperative period.]
- Perioperative acute kidney injury (AKI) [Time frame: Postoperative days 0 to 7]
Secondary outcome measures (6)
- Incidence of prolonged preoperative fasting for clear liquids [Time frame: 48 hours preoperatively]
- Severity of prolonged clear liquid fasting [Time frame: 48 hours preoperatively]
- Perioperative hypoglycemia [Time frame: 12 hours preoperatively to 24 hours postoperatively]
- Perioperative hyperglycemia [Time frame: 12 hours preoperatively to 24 hours postoperatively]
- Perioperative AKI stage 2 or higher. [Time frame: Postoperative days 0 to 7]
- Myocardial injury after noncardiac surgery (MINS) [Time frame: Postoperative day 0 to 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospital — Boston
Identifiers
NCT: NCT07022951 · 2023P001743