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Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05436236
Recruitment Status : Not yet recruiting
First Posted : June 29, 2022
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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
Gastric Emptying Cannabis

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort
Control
People who self-report that they do not use cannabis.
Cannabis
People who self-report that they use cannabis.



Primary Outcome Measures :
  1. Gastric content volume [ Time Frame: pre-operative ]
    Gastric content volume as assessed by ultrasound prior to surgery


Secondary Outcome Measures :
  1. Frequency of cannabis use [ Time Frame: 3 months prior to surgery ]
    number of times per week patient uses cannabis

  2. Cannabis use (chronic yes or no) [ Time Frame: 1 year prior to surgery ]
    Yes or No for chronic cannabis use

  3. Route of cannabis consumption [ Time Frame: 3 months prior to surgery ]
    Categories of how cannabis is consumed (smoke, vape, other)

  4. Time since last food; Nil per os (NPO) time [ Time Frame: 24 hours prior to surgery ]
    Length of time patient had no food prior to surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436236


Contacts
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Contact: Michael Grover, MD 570-887-4882 Michael.Grover@guthrie.org
Contact: Neel Kapoor, DO 570-887-4882 Neel.Kapoor@guthrie.org

Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Neel Kapoor, DO The Guthrie Clinic
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT05436236    
Other Study ID Numbers: 2204-15
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders