Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07022951

Conditions

Anesthesia

Sedation

Monitored Anesthesia Care

Procedure

Surgery, Day

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Preoperative fasting

Study Details

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. 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.

Conditions

Anesthesia

Sedation

Monitored Anesthesia Care

Procedure

Surgery, Day

Study ID

NCT07022951

Start date

Jan 1, 2016

Status verified date

Mar, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

1200000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients who receive anesthesia care

Interventions

Preoperative fasting

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

Primary outcome measure

  • Postoperative nausea and vomiting (PONV) [ Time Frame: 12 hours postoperatively ]
  • Intraoperative hypotension [ Time Frame: Intraoperative period. ]
  • Perioperative acute kidney injury (AKI) [ Time Frame: Postoperative days 0 to 7 ]

Central Contacts and Locations

Central contacts

Alexander Nagrebetsky, MD, MSc

617-724-3292anagrebetsky@mgh.harvard.edu

Locations

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alexander Nagrebetsky, MD, MSc

617-724-3292anagrebetsky@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 8, 2026

Last verified

Mar, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-08.