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NCT07022951Recruiting

The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes

Massachusetts General Hospital

Start Date

1/1/2016

Completion Date

12/31/2030

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

OTHER

Preoperative fasting

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Conditions

AnesthesiaSedationMonitored Anesthesia CareProcedureSurgery, DaySurgerySurgery ScheduledFasting Before OperationAspiration; Gastric Contents, Anesthesia

Locations

Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospitals

Boston, Massachusetts 02114

United States