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Principal Investigator failed to submit required annual review. Study was administratively closed by the IRB.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-users | Active Comparator | Patients that don't use cannabis and will be submitted to sedation. |
|
| Users that will stop use 72h before the procedure | Experimental | Patients that use cannabis and will stop using 72 hours before sedation. |
|
| Users that will stop use 12h before the procedure | Experimental | Patients that use cannabis and will stop using 12 hours before sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation with Midazolam, Fentanyl, and Propofol | Drug | Patients will have teeth extracted under sedation with Midazolam, Fentanyl, and Propofol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Propofol dose in milligrams | Compare the total amount of propofol necessary to sedate patients that use cannabis with patients that do not use | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate in beats per minute | Compare how the heart rate behave during the procedure in each group | During the procedure |
| Blood pressure in millimeters of mercury | Compare how the blood pressure behave during the procedure in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D015742 | Propofol |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Extraction of teeth | Procedure | The necessary teeth will be extracted |
|
|
| During the procedure |
| 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 | During the procedure |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |