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

NCT06867068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • Anesthesia
  • Tooth Extraction

Interventions

DRUG

Midazolam Hydrochloride

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

DRUG

Fentanyl

Synthetic opioid drug used as an analgesic.

DRUG

Ketamine

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

DRUG

Propofol injection

General Anesthetic. GABA receptor modulator and calcium channel blocker

DRUG

Nitrous oxide

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

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Stephen S Gelfman, MD, DDS · New York City Health and Hospitals (NYCHHC)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2024-06-10
Completion
2024-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06867068 on ClinicalTrials.gov