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

Mass General Brigham

Status: Enrolling

Conditions: Aspiration; Gastric Contents, Anesthesia; Procedure; Surgery, Day; Surgery Scheduled; Surgery; Fasting Before Operation; Monitored Anesthesia Care; Sedation; Anesthesia

Treatments: Other: Preoperative fasting

Study type: Observational

Funder types: Other

Identifiers

NCT07022951

2023P001743

Details and patient eligibility

About

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. We 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.

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.

Enrollment: 1,200,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,200,000 participants in 1 patient group

Patients who receive anesthesia care

Treatment:

Other: Preoperative fasting