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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07022951
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preoperative fasting — OTHER
    This cohort study assesses the duration of preoperative fasting and its clinical effects

Study Details

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.

Key Dates

Start date
Jan 1, 2016
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
1,200,000 participants (estimated)

Arms

  • Arm: Patients who receive anesthesia care

Primary Outcome Measure

Postoperative nausea and vomiting (PONV) [ Time Frame: 12 hours postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospitalsBostonMassachusetts02114
Alexander Nagrebetsky, MD, MSc
[email protected]
617-724-3292

Find similar trials in Boston, MA

By research site
Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospitals· Boston, MA

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