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NCT06867068 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
Phase 1
Development phase
73
Enrollment target

NCT06867068: Completed Phase 1 study, sponsored by Albert Einstein College of Medicine.

NCT06867068 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06867068, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
73 participants
Enrollment target

Study 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.

Primary Outcome

Patient satisfaction was assessed using a patient evaluation survey administered following the procedure just prior to discharge. The survey consisted of 3 questions, 1 categorical and 2 ordinal. For purposes of this study, the 2 ordinal measures: "How do you feel now?" and "I would recommend this type of intravenous sedation to my family/friends" will be scored from 1-3 and 1-4, respectively for an overall possible scoring range of 2-7. Higher scores are associated with increased patient satisf

Interventions

  • DRUG Ketamine
  • DRUG Nitrous oxide
  • DRUG Fentanyl
  • DRUG Midazolam Hydrochloride
  • DRUG Propofol injection

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2016-10-04
Est. Completion 2024-06-10
Phase Phase 1
Albert Einstein College of Medicine

175 total trials

What the finished NCT06867068 record still lists

NCT06867068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).

The record links to 0 conditions, and to 5 interventions - of which Ketamine is the first listed.

NCT06867068 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06867068 about?

NCT06867068 is a clinical study titled "Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery". 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 testi...

What is the current status of trial NCT06867068?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2016-10-04. Estimated completion is 2024-06-10.

What interventions are being tested in trial NCT06867068?

The interventions under investigation include: Ketamine (DRUG), Nitrous oxide (DRUG), Fentanyl (DRUG), Midazolam Hydrochloride (DRUG), Propofol injection (DRUG).

Who is sponsoring clinical trial NCT06867068?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06867068's enrollment target sits among peer trials

73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06867068, the US trial registry maintained by the National Library of Medicine. NCT06867068 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.