Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
NCT ID: NCT06867068
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2016-10-04
2024-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Ketamine Group
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.
Midazolam Hydrochloride
Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor
Fentanyl
Synthetic opioid drug used as an analgesic.
Ketamine
General Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist
Nitrous oxide
Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents
Propofol Group
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.
Midazolam Hydrochloride
Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor
Fentanyl
Synthetic opioid drug used as an analgesic.
Propofol injection
General Anesthetic. GABA receptor modulator and calcium channel blocker
Nitrous oxide
Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents
Interventions
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Midazolam Hydrochloride
Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor
Fentanyl
Synthetic opioid drug used as an analgesic.
Ketamine
General Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist
Propofol injection
General Anesthetic. GABA receptor modulator and calcium channel blocker
Nitrous oxide
Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Existing clinical population
16 Years
ALL
Yes
Sponsors
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Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Stephen S Gelfman, MD, DDS
Role: PRINCIPAL_INVESTIGATOR
New York City Health and Hospitals (NYCHHC)
Locations
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NYCHHC - Jacobi Medical Center and North Central Bronx Hospital
The Bronx, New York, United States
Countries
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References
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American Association of Oral and Maxillofacial Surgeons Parameters of Care: Clinical Practice Guidelines. 2012.
Peskin RM. Contemporary intravenous anesthetic agents and delivery systems: propofol. Anesth Prog. 1992;39(4-5):178-84. No abstract available.
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.
Craig DC, Wildsmith JA; Royal College of Anaesthetists; Royal College of Surgeons of England. Conscious sedation for dentistry: an update. Br Dent J. 2007 Dec 8;203(11):629-31. doi: 10.1038/bdj.2007.1105.
Goktay O, Satilmis T, Garip H, Gonul O, Goker K. A comparison of the effects of midazolam/fentanyl and midazolam/tramadol for conscious intravenous sedation during third molar extraction. J Oral Maxillofac Surg. 2011 Jun;69(6):1594-9. doi: 10.1016/j.joms.2010.09.005. Epub 2011 Feb 1.
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.
Ulmer BJ, Hansen JJ, Overley CA, Symms MR, Chadalawada V, Liangpunsakul S, Strahl E, Mendel AM, Rex DK. Propofol versus midazolam/fentanyl for outpatient colonoscopy: administration by nurses supervised by endoscopists. Clin Gastroenterol Hepatol. 2003 Nov;1(6):425-32. doi: 10.1016/s1542-3565(03)00226-x.
Personal Communication. Oral and Maxillofacial Surgery National Insurance Company. 2013.
Blankstein KC. Low-dose intravenous ketamine: an effective adjunct to conventional deep conscious sedation. J Oral Maxillofac Surg. 2006 Apr;64(4):691-2. doi: 10.1016/j.joms.2005.11.038. No abstract available.
Casagrande AM. Propofol for office oral and maxillofacial anesthesia: the case against low-dose ketamine. J Oral Maxillofac Surg. 2006 Apr;64(4):693-5. doi: 10.1016/j.joms.2005.11.039. No abstract available.
Cillo JE Jr. Analysis of propofol and low-dose ketamine admixtures for adult outpatient dentoalveolar surgery: a prospective, randomized, positive-controlled clinical trial. J Oral Maxillofac Surg. 2012 Mar;70(3):537-46. doi: 10.1016/j.joms.2011.08.036. Epub 2011 Dec 16.
Driscoll EJ, Gelfman SS, Sweet JB, Butler DP, Wirdzck PR, Medlin T. Thrombophlebitis after intravenous use of anesthesia and sedation: its incidence and natural history. J Oral Surg. 1979 Nov;37(11):809-15.
Haas DA, Harper DG. Ketamine: a review of its pharmacologic properties and use in ambulatory anesthesia. Anesth Prog. 1992;39(3):61-8.
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.
Kramer KJ, Ganzberg S, Prior S, Rashid RG. Comparison of propofol-remifentanil versus propofol-ketamine deep sedation for third molar surgery. Anesth Prog. 2012 Fall;59(3):107-17. doi: 10.2344/12-00001.1.
Senel AC, Altintas NY, Senel FC, Pampu A, Tosun E, Ungor C, Dayisoylu EH, Tuzuner T. Evaluation of sedation in oral and maxillofacial surgery in ambulatory patients: failure and complications. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Nov;114(5):592-6. doi: 10.1016/j.oooo.2012.03.008. Epub 2012 Aug 15.
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.
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.
Lepere AJ, Slack-Smith LM. Average recovery time from a standardized intravenous sedation protocol and standardized discharge criteria in the general dental practice setting. Anesth Prog. 2002 Summer;49(3):77-81.
Takarada T, Kawahara M, Irifune M, Endo C, Shimizu Y, Maeoka K, Tanaka C, Katayama S. Clinical recovery time from conscious sedation for dental outpatients. Anesth Prog. 2002 Winter;49(4):124-7.
Becker DE. Pharmacokinetic considerations for moderate and deep sedation. Anesth Prog. 2011 Fall;58(4):166-72; quiz 173. doi: 10.2344/0003-3006-58.4.166.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2014-3556
Identifier Type: -
Identifier Source: org_study_id
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