Back to resultsCannabis Use on Sedation for Oral Surgery Procedures
Primary Purpose
Cannabis Use
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sedation with Midazolam, Fentanyl, and Propofol
Extraction of teeth
Sponsored by
About this trial
This is an interventional diagnostic trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years of age Class I or II according to the American Society of Anesthesiology (ASA) Need for dental extractions Extraction procedures with similar level of complexity Exclusion Criteria: Surgical time lesser than 10 or greater than 30 minutes ASA status of III or greater BMI greater than 30 k/m2 Pregnancy Use of anti-depressants, sedatives, or other mood-altering medications History of illicit substance abuse, alcoholism, or chronic opioid use
Sites / Locations
- College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Non-users
Users that will stop use 72h before the procedure
Users that will stop use 12h before the procedure
Arm Description
Patients that don't use cannabis and will be submitted to sedation.
Patients that use cannabis and will stop using 72 hours before sedation.
Patients that use cannabis and will stop using 12 hours before sedation.
Outcomes
Primary Outcome Measures
Propofol dose in milligrams
Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use
Secondary Outcome Measures
Heart rate in beats per minute
Compare how the heart rate behave during the procedure in each group
Blood pressure in millimeters of mercury
Compare how the blood pressure behave during the procedure in each group
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale
Compare the difference in sedation quality during the procedure in each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05873465
Brief Title
Cannabis Use on Sedation for Oral Surgery Procedures
Official Title
Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 22, 2023 (Anticipated)
Primary Completion Date
May 21, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-users
Arm Type
Active Comparator
Arm Description
Patients that don't use cannabis and will be submitted to sedation.
Arm Title
Users that will stop use 72h before the procedure
Arm Type
Experimental
Arm Description
Patients that use cannabis and will stop using 72 hours before sedation.
Arm Title
Users that will stop use 12h before the procedure
Arm Type
Experimental
Arm Description
Patients that use cannabis and will stop using 12 hours before sedation.
Intervention Type
Drug
Intervention Name(s)
Sedation with Midazolam, Fentanyl, and Propofol
Other Intervention Name(s)
Sedation
Intervention Description
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
Intervention Type
Procedure
Intervention Name(s)
Extraction of teeth
Other Intervention Name(s)
Surgical procedure
Intervention Description
The necessary teeth will be extracted
Primary Outcome Measure Information:
Title
Propofol dose in milligrams
Description
Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Heart rate in beats per minute
Description
Compare how the heart rate behave during the procedure in each group
Time Frame
During the procedure
Title
Blood pressure in millimeters of mercury
Description
Compare how the blood pressure behave during the procedure in each group
Time Frame
During the procedure
Title
Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale
Description
Compare the difference in sedation quality during the procedure in each group
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years of age
Class I or II according to the American Society of Anesthesiology (ASA)
Need for dental extractions
Extraction procedures with similar level of complexity
Exclusion Criteria:
Surgical time lesser than 10 or greater than 30 minutes
ASA status of III or greater
BMI greater than 30 k/m2
Pregnancy
Use of anti-depressants, sedatives, or other mood-altering medications
History of illicit substance abuse, alcoholism, or chronic opioid use
Facility Information:
Facility Name
College of Dentistry
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Ritto, DDS, MD, PhD
Phone
405-271-4441
Email
fabio-ritto@ouhsc.edu
12. IPD Sharing Statement
Learn more about this trial
Cannabis Use on Sedation for Oral Surgery Procedures
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