WithdrawnPhase 4

Use of Remimazolam and Fentanyl for Procedural Sedation in Patients Undergoing Dental Extraction

Stopped: No one was enrolled to date and the sponsor requested the study be withdrawn

United States0Started 2025-07-31

Plain-language summary

The goal of this clinical trial is to learn if a combination of the two established sedation drugs remimazolam and fentanyl, can put the subject to sleep during a scheduled extraction procedure. The combined use of these drugs has been used in other studies involving IV sedation when the procedure is scheduled for 30 minutes or less. However, the combined use of the IV sedation drugs has not been used in a dental extraction procedure before. The main questions it aims to answer are: 1. Can the combined drugs effectively put the patient to sleep during the procedure 2. How quickly will they come out of the sedation after the procedure Participants will: 1. Receive the combined drugs during a scheduled extraction procedure anticipated to take less than 30 minutes 2. Answer survey questions related to their study experience after the extraction visit (in person) and again about 24 hours after the visit (by telephone).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Outcome Measure for IV Sedation for completion of Surgery using successful extraction of teeth (1)

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery (2) using MOAA/s scores (

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery determined by no need for rescue medications (3)

Timeframe: 30 minutes extraction period at the end of surgery

Trial details

NCT IDNCT06793358

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Dental Extraction trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Primary Outcome Measure for IV Sedation for completion of Surgery using successful extraction of teeth (1)

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery (2) using MOAA/s scores (

Timeframe: 30 minutes extraction period at the end of surgery

Primary Outcome Measure for IV Sedation for completion of Surgery determined by no need for rescue medications (3)

Timeframe: 30 minutes extraction period at the end of surgery