Cannabis Use on Sedation for Oral Surgery Procedures

NCT ID: NCT05873465

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Non-users

Patients that don't use cannabis and will be submitted to sedation.

Group Type ACTIVE_COMPARATOR

Sedation with Midazolam, Fentanyl, and Propofol

Intervention Type DRUG

Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Extraction of teeth

Intervention Type PROCEDURE

The necessary teeth will be extracted

Users that will stop use 72h before the procedure

Patients that use cannabis and will stop using 72 hours before sedation.

Group Type EXPERIMENTAL

Sedation with Midazolam, Fentanyl, and Propofol

Intervention Type DRUG

Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Extraction of teeth

Intervention Type PROCEDURE

The necessary teeth will be extracted

Users that will stop use 12h before the procedure

Patients that use cannabis and will stop using 12 hours before sedation.

Group Type EXPERIMENTAL

Sedation with Midazolam, Fentanyl, and Propofol

Intervention Type DRUG

Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Extraction of teeth

Intervention Type PROCEDURE

The necessary teeth will be extracted

Interventions

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Sedation with Midazolam, Fentanyl, and Propofol

Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol

Intervention Type DRUG

Extraction of teeth

The necessary teeth will be extracted

Intervention Type PROCEDURE

Other Intervention Names

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Sedation Surgical procedure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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College of Dentistry

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Fabio Ritto, DDS, MD, PhD

Role: primary

405-271-4441

Other Identifiers

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15416

Identifier Type: -

Identifier Source: org_study_id

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