RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-01-01
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07022951

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)
  1. * Not receiving anesthesia care
  2. * Lack of medical record data in Epic electronic medical record system

Contacts and Locations

Study Contact

Alexander Nagrebetsky, MD, MSc
CONTACT
617-724-3292
anagrebetsky@mgh.harvard.edu

Study Locations (Sites)

Mass General Brigham
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01-01
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2016-01-01
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • preoperative fasting
  • perioperative pulmonary aspiration
  • perioperative complications
  • postoperative nausea and vomiting
  • perioperative hypoglycemia
  • perioperative hyperglycemia
  • perioperative hypotension
  • myocardial injury after noncardiac surgery
  • perioperative acute kidney injury
  • clear liquid fasting

Additional Relevant MeSH Terms

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