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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05436236
Other study ID # 2204-15
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 1, 2024
Est. completion date December 1, 2026

Study information

Verified date February 2024
Source The Guthrie Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Guthrie Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric content volume Gastric content volume as assessed by ultrasound prior to surgery pre-operative
Secondary Frequency of cannabis use number of times per week patient uses cannabis 3 months prior to surgery
Secondary Cannabis use (chronic yes or no) Yes or No for chronic cannabis use 1 year prior to surgery
Secondary Route of cannabis consumption Categories of how cannabis is consumed (smoke, vape, other) 3 months prior to surgery
Secondary Time since last food; Nil per os (NPO) time Length of time patient had no food prior to surgery 24 hours prior to surgery
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