Clinical trial NCT06867068: Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
Official title: Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anesthesia
Tooth Extraction
Keywords: Ambulatory Oral Surgery
Maxillofacial Surgery
Intravenous
Ketamine
Propofol
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 73
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Do not meet the Inclusion Criteria

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Postoperatively, approximately 1 hour on day of procedure
measure: Surgeon Satisfaction
timeFrame: Postoperatively, approximately 1 hour
measure: Recovery - Paper Test
timeFrame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
measure: Recovery - One Leg Standing Test
timeFrame: Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure
measure: Amnesia - Visual Stimuli
timeFrame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
measure: Amnesia - Tactile Stimuli
timeFrame: Intraoperatively and postoperatively, up to 1-2 hours on day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: NYCHHC - Jacobi Medical Center and North Central Bronx Hospital
state: New York
Study officials:
affiliation: New York City Health and Hospitals (NYCHHC)
name: Stephen S Gelfman, MD, DDS
role: PRINCIPAL_INVESTIGATOR
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