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

NCT06793358 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-03-03

No results posted yet for this study

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).

Conditions

  • Dental Extraction

Interventions

DRUG

fentanyl and Remimazolam

This is the first dental study that will combine these two sedation drugs

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • kyle j kramer, DDS · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-02-27
Completion
2026-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793358 on ClinicalTrials.gov