Clinical trial NCT06567873: Gastric Ultrasound Assessment for Patients Taking Cannabis
Official title: Assessment of Preoperative Gastric Content With Ultrasound in Patients Reporting Cannabis Use
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Ultrasound
Point of Care Ultrasound
Cannabis Use
Keywords: cannabis
gastric ultrasound
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be comprised of patients scheduled for surgery at HSS who meet the following inclusion criteria and none of the exclusion criteria.

Brief summary: The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who report cannabis use.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delayed gastric emptying
timeFrame: This will be measured pre-operatively in the holding room area.
Secondary outcomes:
measure: Nothing by mouth (NPO) intervals
timeFrame: This will be measured pre-operatively in the holding room area.
measure: Presence of gastric peristalsis
timeFrame: This will be measured pre-operatively in the holding room area.
measure: Time interval since last cannabis use
timeFrame: This will be measured pre-operatively in the holding room area.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Oliver Panzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.