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

NCT ID: NCT07022951

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients who receive anesthesia care

Preoperative fasting

Intervention Type OTHER

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

Interventions

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Preoperative fasting

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexander Nagrebetsky, MD MSc

Physician-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mass General Brigham

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alexander Nagrebetsky, MD, MSc

Role: CONTACT

617-724-3292

Facility Contacts

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Alexander Nagrebetsky, MD, MSc

Role: primary

617-724-3292

Other Identifiers

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2023P001743

Identifier Type: -

Identifier Source: org_study_id

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