NCT05436236

Brief Summary

The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Dec 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

June 23, 2022

Last Update Submit

February 13, 2024

Conditions

Gastric EmptyingCannabis

Outcome Measures

Primary Outcomes (1)

  • Gastric content volume

    Gastric content volume as assessed by ultrasound prior to surgery

    pre-operative

Secondary Outcomes (4)

  • Frequency of cannabis use

    3 months prior to surgery

  • Cannabis use (chronic yes or no)

    1 year prior to surgery

  • Route of cannabis consumption

    3 months prior to surgery

  • Time since last food; Nil per os (NPO) time

    24 hours prior to surgery

Study Arms (2)

Control

People who self-report that they do not use cannabis.

Cannabis

People who self-report that they use cannabis.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18 years and older with a planned surgery at one of two hospitals within the healthcare system, who are willing to state if they use or do not use cannabis

You may qualify if:

  • Subjects 18 years and older
  • Planned surgery at one of two hospitals within the healthcare system
  • Willing to state if they use or do not use cannabis
  • Able to read and consent on their own behalf

You may not qualify if:

  • Cognitively impaired
  • Unable to read
  • Children under the age of 18
  • Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery
  • History of gastroparesis
  • Gastric surgeries
  • Advanced liver or renal dysfunction
  • Critically ill
  • Emergent/urgent cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Neel Kapoor, DO

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share