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Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery

Sponsor
The Guthrie Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05436236
Collaborator
(none)
108
Enrollment
23
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen.

    Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    108 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Cannabis Consumption Effect on Gastric Volumes
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Control

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

    People who self-report that they use cannabis.

    Outcome Measures

    Primary Outcome Measures

    1. Gastric content volume [pre-operative]

      Gastric content volume as assessed by ultrasound prior to surgery

    Secondary Outcome Measures

    1. Frequency of cannabis use [3 months prior to surgery]

      number of times per week patient uses cannabis

    2. Cannabis use (chronic yes or no) [1 year prior to surgery]

      Yes or No for chronic cannabis use

    3. Route of cannabis consumption [3 months prior to surgery]

      Categories of how cannabis is consumed (smoke, vape, other)

    4. Time since last food; Nil per os (NPO) time [24 hours prior to surgery]

      Length of time patient had no food prior to surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Guthrie Clinic

    Investigators

    • Principal Investigator: Neel Kapoor, DO, The Guthrie Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Guthrie Clinic
    ClinicalTrials.gov Identifier:
    NCT05436236
    Other Study ID Numbers:
    • 2204-15
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Marijuana Abuse

    Study Results

    No Results Posted as of Aug 24, 2022