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Cannabis Use on Sedation for Oral Surgery Procedures

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ClinicalTrials.gov Identifier: NCT05873465
Recruitment Status : Recruiting
First Posted : May 24, 2023
Last Update Posted : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cannabis Use Drug: Sedation with Midazolam, Fentanyl, and Propofol Procedure: Extraction of teeth Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Cannabis Use on Sedation Requirements for Oral Surgery Procedures
Actual Study Start Date : March 14, 2023
Estimated Primary Completion Date : May 21, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Non-users
Patients that don't use cannabis and will be submitted to sedation.
 Drug: Sedation with Midazolam, Fentanyl, and Propofol
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
Other Name: Sedation

Procedure: Extraction of teeth
The necessary teeth will be extracted
Other Name: Surgical procedure
Experimental: Users that will stop use 72h before the procedure
Patients that use cannabis and will stop using 72 hours before sedation.
 Drug: Sedation with Midazolam, Fentanyl, and Propofol
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
Other Name: Sedation

Procedure: Extraction of teeth
The necessary teeth will be extracted
Other Name: Surgical procedure
Experimental: Users that will stop use 12h before the procedure
Patients that use cannabis and will stop using 12 hours before sedation.
 Drug: Sedation with Midazolam, Fentanyl, and Propofol
Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol
Other Name: Sedation

Procedure: Extraction of teeth
The necessary teeth will be extracted
Other Name: Surgical procedure


Outcome Measures
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Primary Outcome Measures :
  1. Propofol dose in milligrams [ Time Frame: During the procedure ]
    Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use


Secondary Outcome Measures :
  1. Heart rate in beats per minute [ Time Frame: During the procedure ]
    Compare how the heart rate behave during the procedure in each group

  2. Blood pressure in millimeters of mercury [ Time Frame: During the procedure ]
    Compare how the blood pressure behave during the procedure in each group

  3. Quality of sedation grading from 0 to 6 according to the Observer's Assessment of Alertness/Sedation scale [ Time Frame: During the procedure ]
    Compare the difference in sedation quality during the procedure in each group


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT05873465


Locations
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United States, Oklahoma
College of Dentistry Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Fabio Ritto, DDS, MD, PhD    405-271-4441    fabio-ritto@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT05873465    
Other Study ID Numbers: 15416
First Posted: May 24, 2023    Key Record Dates
Last Update Posted: February 14, 2024
Last Verified: February 2024

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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
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Midazolam
Fentanyl
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
 Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents