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

NCT06867068 | Completed Phase 1 FDA Drug

• 1 other identifier: 2014-3556
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Tooth Extraction

Keywords

Ambulatory Oral Surgery; Maxillofacial Surgery; Intravenous; Ketamine; Propofol

Outcome Measures

Primary Outcomes (6)

• Patient Satisfaction

  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.

  Postoperatively, approximately 1 hour on day of procedure

• Surgeon Satisfaction

  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.

  Postoperatively, approximately 1 hour

• Recovery - Paper Test

  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.

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

• Recovery - One Leg Standing Test

  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.

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

• Amnesia - Visual Stimuli

  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.

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

• Amnesia - Tactile Stimuli

  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.

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

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

1. Midazolam 0.05 mg/kg - rounded to closest ½ mg 2. Fentanyl 50 micrograms (mcg) for patients less than or equal to 70kg and 75 mcg for those over 70 kg 3. Ketamine 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5mg Midazolam, 50 mcg Fentanyl, 20 mg Ketamine) 4. Additional intermittent dosage of Ketamine - 15 mg per surgeon's request All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label.

Drug: Midazolam Hydrochloride; Drug: Fentanyl; Drug: Ketamine; Drug: Nitrous oxide

Propofol Group

ACTIVE COMPARATOR

1. Midazolam 0.05 mg/kg - rounded to closest ½ mg 2. Fentanyl 50 mcg for patients less than or equal to 70 kg and 75 mcg for those over 70 kg 3. Propofol 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5 mg Midazolam, 50 micrograms Fentanyl, 20 mg Propofol) 4. Additional intermittent dosage of Propofol - 15 mg per surgeon's request All patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label.

Drug: Midazolam Hydrochloride; Drug: Fentanyl; Drug: Propofol injection; Drug: Nitrous oxide

Interventions

Fentanyl DRUG

Synthetic opioid drug used as an analgesic.

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

Ketamine Group; Propofol Group

Ketamine DRUG

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

Also known as: Ketalar

Ketamine Group

Propofol injection DRUG

General Anesthetic. GABA receptor modulator and calcium channel blocker

Also known as: 2,6-diisopropylphenol; Diprivan

Propofol Group

Nitrous oxide DRUG

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

Also known as: Nitrous, laughing gas

Ketamine Group; Propofol Group

Midazolam Hydrochloride DRUG

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

Also known as: Versed

Ketamine Group; Propofol Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

NYCHHC - Jacobi Medical Center and North Central Bronx Hospital

The Bronx, New York, 10461, United States

Location

Related Publications (25)

• American Association of Oral and Maxillofacial Surgeons Parameters of Care: Clinical Practice Guidelines. 2012.

  BACKGROUND

• Braidy HF, Singh P, Ziccardi VB. Safety of deep sedation in an urban oral and maxillofacial surgery training program. J Oral Maxillofac Surg. 2011 Aug;69(8):2112-9. doi: 10.1016/j.joms.2011.04.017.

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• Peskin RM. Contemporary intravenous anesthetic agents and delivery systems: propofol. Anesth Prog. 1992;39(4-5):178-84. No abstract available.

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• Sims PG, Kates CH, Moyer DJ, Rollert MK, Todd DW. Anesthesia in outpatient facilities. J Oral Maxillofac Surg. 2012 Nov;70(11 Suppl 3):e31-49. doi: 10.1016/j.joms.2012.07.030. No abstract available.

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  BACKGROUND

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• Haas DA, Harper DG. Ketamine: a review of its pharmacologic properties and use in ambulatory anesthesia. Anesth Prog. 1992;39(3):61-8.

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• Idvall J, Ahlgren I, Aronsen KR, Stenberg P. Ketamine infusions: pharmacokinetics and clinical effects. Br J Anaesth. 1979 Dec;51(12):1167-73. doi: 10.1093/bja/51.12.1167.

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  PMID: 22901639 BACKGROUND

• Gelfman SS, Gracely RH, Driscoll EJ, Wirdzek PR, Butler DP, Sweet JB. Comparison of recovery tests after intravenous sedation with diazepam-methohexital and diazepam-methohexital and fentanyl. J Oral Surg. 1979 Jun;37(6):391-7.

  PMID: 286027 BACKGROUND

• Gelfman SS, Gracely RH, Driscoll EJ, Butler D, Sweet JB, Wirdzek PR. Recovery following intravenous sedation during dental surgery performed under local anesthesia. Anesth Analg. 1980 Oct;59(10):775-81.

  PMID: 7191651 BACKGROUND

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• Gelfman SS, Gracely RH, Driscoll EJ, Wirdzek PR, Sweet JB, Butler DP. Conscious sedation with intravenous drugs: a study of amnesia. J Oral Surg. 1978 Mar;36(3):191-7.

  PMID: 272450 BACKGROUND

• Miller RI, Bullard DE, Patrissi GA. Duration of amnesia associated with midazolam/fentanyl intravenous sedation. J Oral Maxillofac Surg. 1989 Feb;47(2):155-8. doi: 10.1016/s0278-2391(89)80108-9.

  PMID: 2913250 BACKGROUND

• Bennett J, Peterson T, Burleson JA. Capnography and ventilatory assessment during ambulatory dentoalveolar surgery. J Oral Maxillofac Surg. 1997 Sep;55(9):921-5;discussion 925-6. doi: 10.1016/s0278-2391(97)90058-6.

  PMID: 9294499 BACKGROUND

• Dionne RA, Driscoll EJ, Gelfman SS, Sweet JB, Butler DP, Wirdzek PR. Cardiovascular and respiratory response to intravenous diazepam, fentanyl, and methohexital in dental outpatients. J Oral Surg. 1981 May;39(5):343-9.

  PMID: 6938649 BACKGROUND

MeSH Terms

Interventions

Midazolam; Fentanyl; Ketamine; Propofol; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Stephen S Gelfman, MD, DDS

  New York City Health and Hospitals (NYCHHC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: For purposes of safety the anesthesiologist was not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: October 4, 2016
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)