CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
Midazolam Hydrochloride +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06867068
NCT06867068Phase 1Completed

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery

Albert Einstein College of Medicine·interventional·Posted Mar 10, 2025·Updated Mar 27, 2026

In Brief

A Phase 1 clinical trial evaluating Midazolam Hydrochloride, Fentanyl, and 3 other interventions for Anesthesia and Tooth Extraction. Completed, enrolled 73 participants across 1 site.

Detailed Summary

The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Measures of recovery, amnesia testing 20 minutes after induction and after completion of recovery tests, patient satisfaction, and surgeon satisfaction will be evaluated. The data from this pilot study will be used to obtain preliminary estimates of effect sizes and to select primary and secondary endpoints for the design of a larger scale and more definitive trial of the two anesthetic approaches.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 10, 2025
Enrollment StartOct 4, 2016
Primary CompletionJun 10, 2024
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 1.3 years ago

Interventions

Midazolam Hydrochloridedrug

Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor

Fentanyldrug

Synthetic opioid drug used as an analgesic.

Ketaminedrug

General Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist

Propofol injectiondrug

General Anesthetic. GABA receptor modulator and calcium channel blocker

Nitrous oxidedrug

Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents