Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07022951

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Alexander Nagrebetsky, MD, MSc

CONTACT

[email protected]

617-724-3292

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative fasting

Other

This cohort study assesses the duration of preoperative fasting and its clinical effects

Primary outcomes

  1. Postoperative nausea and vomiting (PONV)

    Time frame: 12 hours postoperatively

    The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h postoperatively.

  2. Intraoperative hypotension

    Time frame: Intraoperative period.

    The co-primary outcome of intraoperative hypotension is defined as an area under the curve of intraoperative mean arterial pressure <65 mm Hg.

  3. Perioperative acute kidney injury (AKI)

    Time frame: Postoperative days 0 to 7

    The co-primary outcome of perioperative AKI is defined as stage 1 or higher, based on Kidney Disease Improving Global Outcomes criteria (creatinine rise ≥ 0.3 mg/dl within 48 h or ≥ 1.5 times baseline) from postoperative day (POD) 0 until POD 7

Secondary outcomes

  1. Incidence of prolonged preoperative fasting for clear liquids

    Time frame: 48 hours preoperatively

    Incidence of prolonged preoperative fasting for clear liquids is defined as fasting that exceeds the American Society of Anesthesiologists-recommended duration by a factor of 2 or more (≥ 4 hours).

  2. Severity of prolonged clear liquid fasting

    Time frame: 48 hours preoperatively

    Severity of prolonged clear liquid fasting is defined as the frequency of fasting duration that exceeds the currently recommended by 2x, 4x, 6x, etc.

  3. Perioperative hypoglycemia

    Time frame: 12 hours preoperatively to 24 hours postoperatively

    Perioperative hypoglycemia: any blood glucose concentration < 70 mg/dL from 12 h before to 24 h after the procedure

  4. Perioperative hyperglycemia

    Time frame: 12 hours preoperatively to 24 hours postoperatively

    Perioperative hyperglycemia is defined as any blood glucose concentration > 140 mg/dL from 12 h before to 24 h after the procedure.

  5. Perioperative AKI stage 2 or higher.

    Time frame: Postoperative days 0 to 7

    Perioperative AKI stage 2 or higher is defined as creatinine at least twice the baseline level between POD0 to POD7.

  6. Myocardial injury after noncardiac surgery (MINS)

    Time frame: Postoperative day 0 to 3

    Myocardial injury after noncardiac surgery is defined as increased cardiac troponin I above the 99th percentile within 3 days after surgery.

Other outcomes

  1. Safety outcome: Perioperative pulmonary aspiration

    Time frame: Intraoperative period to 24 hours postoperatively

    Perioperative pulmonary aspiration is defined as a clinical case of pulmonary aspiration confirmed either bronchoscopically (within 24h), radiologically (within 24h), or by visualization of aspirate in the airway/hypopharynx.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Nagrebetsky, MD, MSc

CONTACT

[email protected]

617-724-3292

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Anesthesia Patient Safety Foundation (APSF)

Registry information

Official study title

The Million Anesthesia Cases Study (MACS) - Retrospective and Prospective Characterization of Perioperative Fasting Practices and Their Effects on Clinical Outcomes

Acronym: MACS

Important dates

Study start
2016
Primary completion
2028
Study completion
2030
First posted
Jun 15, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.