- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06567873
Gastric Ultrasound Assessment for Patients Taking Cannabis
Assessment of Preoperative Gastric Content With Ultrasound in Patients Reporting Cannabis Use
Study Overview
Status
Intervention / Treatment
Detailed Description
Cannabis use in the United States has continued to increase in recent years, particularly in the adult population. Ease of access through legalization paired with improved public perception has contributed to the uptick in cannabis use. The subset of cannabis users suffering from pain who present for surgery pose a risk for perioperative aspiration due to the slowing of gastric motility due to cannabis use. There is currently no adapted NPO guideline to account for cannabis use.
Gastric Ultrasound (GUS) can be used as a bedside tool for assessing a patient's stomach contents and risk of aspiration. GUS can identify whether a patient's stomach is empty or filled with clear liquid, thick liquid, or solid food. The volume of the stomach can be accurately calculated if there is clear liquid content. A full stomach is categorized as those with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight. As GUS is noninvasive and does not pose risk to patients, it is a useful tool assessing aspiration risk in the preoperative period.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient reporting preoperative cannabis usage within 1 month of surgery date
Exclusion Criteria:
- Patient refusal to participate
- Patient with gastric bypass or any other gastric surgery
- Large hiatal hernia
- Patients with large ascites
- Patients on peritoneal dialysis
- Emergency surgery
- Pre-existing diagnosis of gastroparesis
- Parkinson's disease
- Diabetes
- Currently taking metformin
- Chronic kidney disease stage 3 or higher
- Creatinine ≥ 1.2
- Esophageal surgery
- Currently taking GLP1 agonist medication
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cannabis Users
The cannabis user group will be comprised of patients who report preoperative cannabis use within 1 month of surgery date.
This group will receive the ultrasound exam to assess stomach contents.
|
A gastric ultrasound is a simple, fast, non-invasive bedside diagnostic test that provides a qualitative and quantitative assessment of gastric contents.
There are no known risks of a gastric ultrasound exam.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of delayed gastric emptying
Time Frame: This will be measured pre-operatively in the holding room area.
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A full stomach on gastric ultrasound is defined by the presence of either solid food, thick liquids, or a specific volume (>1.5 ml/kg) of clear liquids on gastric ultrasound.
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This will be measured pre-operatively in the holding room area.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nothing by mouth (NPO) intervals
Time Frame: This will be measured pre-operatively in the holding room area.
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Measure the NPO interval after last solid food and liquid consumption
|
This will be measured pre-operatively in the holding room area.
|
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Presence of gastric peristalsis
Time Frame: This will be measured pre-operatively in the holding room area.
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Gastric peristalsis will be graded as absent, slow, or normal on gastric ultrasound
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This will be measured pre-operatively in the holding room area.
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Time interval since last cannabis use
Time Frame: This will be measured pre-operatively in the holding room area.
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Measure the time from last cannabis consumption to the time the gastric ultrasound was performed
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This will be measured pre-operatively in the holding room area.
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Collaborators and Investigators
Investigators
- Principal Investigator: Oliver Panzer, MD, Hospital for Special Surgery, New York
Publications and helpful links
General Publications
- King DD, Stewart SA, Collins-Yoder A, Fleckner T, Price LL. Anesthesia for Patients Who Self-Report Cannabis (Marijuana) Use Before Esophagogastroduodenoscopy: A Retrospective Review. AANA J. 2021 Jun;89(3):205-212.
- Cammarano CA, Villaluz JE. A Reason to Rethink Fasting Guidelines? Marijuana-Induced Gastroparesis and the Implications for Aspiration Risk in the Nil Per Os (NPO) Patient: A Case Report. Am J Case Rep. 2021 Nov 29;22:e934187. doi: 10.12659/AJCR.934187.
- McCallum RW, Soykan I, Sridhar KR, Ricci DA, Lange RC, Plankey MW. Delta-9-tetrahydrocannabinol delays the gastric emptying of solid food in humans: a double-blind, randomized study. Aliment Pharmacol Ther. 1999 Jan;13(1):77-80. doi: 10.1046/j.1365-2036.1999.00441.x.
- Esfandyari T, Camilleri M, Ferber I, Burton D, Baxter K, Zinsmeister AR. Effect of a cannabinoid agonist on gastrointestinal transit and postprandial satiation in healthy human subjects: a randomized, placebo-controlled study. Neurogastroenterol Motil. 2006 Sep;18(9):831-8. doi: 10.1111/j.1365-2982.2006.00834.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-1155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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