Dental sedation study pulled before it began
NCT ID NCT06793358
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if a combination of remimazolam and fentanyl could safely sedate patients during dental extractions lasting 30 minutes or less. It planned to enroll healthy adults needing tooth removal. However, the trial was withdrawn before any participants were enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remimazolam and fentanyl
- What this could lead to
- If it had worked, this could have pointed toward a safe, fast-acting sedation option for short dental procedures.
- What could go wrong
- The study was withdrawn before any participants were enrolled, so no results are available. The combination had not been tested in dental extractions before.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Started
-
Jul 2025
- Finished
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Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing to read and sign the IRB (Institutional Review Board) approved informed consent document. * Patients 18 years of age and older on the day of the surgery * Healthy patients (ASA Physical Status class of 1 or 2) * Dental treatment consists of planned extractions expected to be completed in 30 minutes or less using IV moderate (procedural) sedation. Exclusion Criteria: List the criteria: * Allergy or negative history with either of the planned sedative medications (remimazolam, fentanyl) or local anesthetics to be used for dental extractions. * Previous negative history with the use of IV sedation medications * Use of opioid-containing analgesics within 24 hours of surgery * BMI \>30 kg/m2 * Patients with multiple or poorly controlled medical comorbidities (i.e., hypertension, COPD (chronic obstructive pulmonary disease), heart failure, asthma, diabetes). * Consumption within the last 24 hours of alcohol, illicit (marijuana, cocaine, etc.), opioid-containing, or other analgesic drugs. * Other contraindications to procedural/moderate sedation (i.e., concurrent illness, failure to follow NPO (nil per os) instructions, lack of escort)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana University School of Dentistry (IUSD)
Indianapolis, Indiana, 46202, United States
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