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

Recruiting

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

• Registration Number: NCT07022951
• Lead Sponsor: Massachusetts General Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of fasting-related perioperative complications: pulmonary aspiration; patient well-being (anxiety, hunger, thirst); circulating blood volume-related complications (hypotension, myocardial and kidney injury); dysglycemia.	Perioperative period - while patient is located in the preoperative area, procedure area, or recovery area.

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States