Skip to main content
OpenTrials
Completed

NCT Number: NCT06867068

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Tooth Extraction

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYCHHC - Jacobi Medical Center and North Central Bronx Hospital

The Bronx, New York, 10461, United States

About this study

The widespread application of various ambulatory anesthetic techniques has paralleled the rapid rise of ambulatory surgery. It has been estimated that over half of all elective surgery is performed in an ambulatory setting. In addition, well over 3,000,000 intravenous sedations are administered in dental offices annually where local anesthesia is obtainable to control intraoperative pain. These intravenous sedation techniques have historically been an integral part of pain and anxiety control in the dental setting and have now gained widespread application in all of ambulatory surgery. A number of intravenous anesthetic techniques have been developed to achieve sedation levels ranging from conscious sedation where patients respond purposefully to verbal commands to deep sedation where patients cannot be easily aroused and protective reflexes may be altered. The goal of all of these techniques is to create a comfortable environment for the patient and a cooperative patient for the surgeon. Ideal technique should pose minimal physiologic challenge to the patient while providing amnesia for the procedure. Most of the intravenous sedation techniques in widespread use include a combination of drugs. These combinations function in an additive if not synergistic way. The pharmacological properties of their constituents achieve this ideal. The most frequently used drug when used alone and the most common to the various combinations is midazolam, a benzodiazepine. Midazolam has been shown to provide safe sedation with reliable anterograde amnesia. The duration of these effects is dose dependent. A short acting narcotic, usually fentanyl, is often times included to increase sedation levels and to add a modicum of analgesia. Other short acting agents can also be included to deepen the sedation level. These agents are usually added in incremental doses as the surgical setting requires. Both propofol and ketamine can induce general anesthesia but in significantly smaller doses provide additional sedation. These two agents come from different drug classes. Proponents of each cite advantages and disadvantages. Nitrous oxide is also commonly used in the dental setting.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) health class I or II
  • Existing clinical population

Exclusion criteria

  • Do not meet the Inclusion Criteria

Treatment and study plan

Midazolam Hydrochloride

Drug

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

Other names: Versed

Fentanyl

Drug

Synthetic opioid drug used as an analgesic.

Other names: (N-phenyl-N-[1-(2-phenylethyl)-4piperidinyl]propanamide); Sublimaze, Actiq, Duragesic, Abstral, Subsys, and Ionsys

ketamine

Drug

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

Other names: Ketalar

Propofol Injection

Drug

General Anesthetic. GABA receptor modulator and calcium channel blocker

Other names: 2,6-diisopropylphenol; Diprivan

Nitrous Oxide

Drug

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

Other names: Nitrous, laughing gas

Primary outcomes

  1. Patient Satisfaction

    Time frame: Postoperatively, approximately 1 hour on day of procedure

    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 satisfaction. Satisfaction scores will be summarized by study arm.

  2. Surgeon Satisfaction

    Time frame: Postoperatively, approximately 1 hour

    Surgeon satisfaction will be assessed by a surgeon's satisfaction survey administered following the procedure. The survey consisted of 3 questions which asked the surgeon to assess their level of satisfaction with the sedation regimen during local anesthesia, during the surgery, and overall satisfaction. Each of the three were rated as 1 ("Poor"), 2 ("Adequate"), or 3 ("Excellent") for an overall possible scoring range of 3-9. Higher scores are associated with increased surgeon satisfaction. Surgeon satisfaction scores will be summarized by study arm.

  3. Recovery - Paper Test

    Time frame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure

    Recovery will be assessed using a simple repeated measure paper and pencil test (PS Form 9a). This test presented participants with 25 rows of numbers. Each row consisted of a circled number at the beginning of the string of numbers. Patients were asked to cross out each number in a row that is like the circled number. The number of successfully completed rows were tabulated for each patient and change from baseline was summarized by study arm.

  4. Recovery - One Leg Standing Test

    Time frame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure

    Recovery will also be assessed by way of a 30 second one leg standing test administered prior to and following induction of anesthesia. The percentage of participants who are able to stand for at least 30 seconds will be summarized by study arm.

  5. Amnesia - Visual Stimuli

    Time frame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure

    Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for visual stimuli will be assessed by having the patient verbally identify common objects (i.e., cup, pen, tape, and keys) presented during surgery. Patients will be asked to recall the items postoperatively. Recall of visual stimuli will be summarized by study arm using basic descriptive statistics.

  6. Amnesia - Tactile Stimuli

    Time frame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure

    Amnesia will be evaluated by interrupting the procedure momentarily at specific intervals (approximately 20 minutes after induction and after completion of recovery test). Amnesia for tactile stimuli will be assessed by touching the patient with a pin on one of their four limbs and asking for recall. Recall of tactile stimuli will be summarized by study arm using basic descriptive statistics.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.