Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-28 @ 5:05 AM
Study NCT ID:
NCT06867068
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-20', 'size': 161564, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-05T16:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'For purposes of safety the anesthesiologist was not blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Postoperatively, approximately 1 hour on day of procedure', 'description': '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.'}, {'measure': 'Surgeon Satisfaction', 'timeFrame': 'Postoperatively, approximately 1 hour', 'description': '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.'}, {'measure': 'Recovery - Paper Test', 'timeFrame': 'Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure', 'description': '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.'}, {'measure': 'Recovery - One Leg Standing Test', 'timeFrame': 'Change from preoperatively to postoperatively, approximately 2-3 hours total on day of procedure', 'description': '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.'}, {'measure': 'Amnesia - Visual Stimuli', 'timeFrame': 'Intraoperatively and postoperatively, up to 1-2 hours on day of procedure', 'description': '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.'}, {'measure': 'Amnesia - Tactile Stimuli', 'timeFrame': 'Intraoperatively and postoperatively, up to 1-2 hours on day of procedure', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ambulatory Oral Surgery', 'Maxillofacial Surgery', 'Intravenous', 'Ketamine', 'Propofol'], 'conditions': ['Anesthesia', 'Tooth Extraction']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'American Association of Oral and Maxillofacial Surgeons Parameters of Care: Clinical Practice Guidelines. 2012.'}, {'pmid': '21783001', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18065980', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21277062', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1344020', 'type': 'BACKGROUND', 'citation': 'Peskin RM. Contemporary intravenous anesthetic agents and delivery systems: propofol. Anesth Prog. 1992;39(4-5):178-84. No abstract available.'}, {'pmid': '23128005', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15017641', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Personal Communication. Oral and Maxillofacial Surgery National Insurance Company. 2013.'}, {'pmid': '16546650', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16546651', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22177821', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '290773', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1308374', 'type': 'BACKGROUND', 'citation': 'Haas DA, Harper DG. Ketamine: a review of its pharmacologic properties and use in ambulatory anesthesia. Anesth Prog. 1992;39(3):61-8.'}, {'pmid': '526385', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23050750', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22901639', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '286027', 'type': 'BACKGROUND', 'citation': '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': '7191651', 'type': 'BACKGROUND', 'citation': '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': '15384295', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12779113', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22168806', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '272450', 'type': 'BACKGROUND', 'citation': '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': '2913250', 'type': 'BACKGROUND', 'citation': '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': '9294499', 'type': 'BACKGROUND', 'citation': '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': '6938649', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) health class I or II\n* Existing clinical population\n\nExclusion Criteria:\n\n* Do not meet the Inclusion Criteria'}, 'identificationModule': {'nctId': 'NCT06867068', 'briefTitle': 'Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery', 'orgStudyIdInfo': {'id': '2014-3556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine Group', 'description': "1. Midazolam 0.05 mg/kg - rounded to closest ½ mg\n2. Fentanyl 50 micrograms (mcg) for patients less than or equal to 70kg and 75 mcg for those over 70 kg\n3. Ketamine 0.3 mg/kg - rounded to closest 5 mg (i.e., 70 kg patient - 3.5mg Midazolam, 50 mcg Fentanyl, 20 mg Ketamine)\n4. Additional intermittent dosage of Ketamine - 15 mg per surgeon's request\n\nAll patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label.", 'interventionNames': ['Drug: Midazolam Hydrochloride', 'Drug: Fentanyl', 'Drug: Ketamine', 'Drug: Nitrous oxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol Group', 'description': "1. Midazolam 0.05 mg/kg - rounded to closest ½ mg\n2. Fentanyl 50 mcg for patients less than or equal to 70 kg and 75 mcg for those over 70 kg\n3. 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)\n4. Additional intermittent dosage of Propofol - 15 mg per surgeon's request\n\nAll patients receive 40% nitrous oxide/oxygen, as per standard clinical care. All of the drugs are being used per label.", 'interventionNames': ['Drug: Midazolam Hydrochloride', 'Drug: Fentanyl', 'Drug: Propofol injection', 'Drug: Nitrous oxide']}], 'interventions': [{'name': 'Midazolam Hydrochloride', 'type': 'DRUG', 'otherNames': ['Versed'], 'description': 'Short-acting sedative. Benzodiazepine. Gamma-aminobutyric acid (GABA) inhibitor', 'armGroupLabels': ['Ketamine Group', 'Propofol Group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['(N-phenyl-N-[1-(2-phenylethyl)-4piperidinyl]propanamide); Sublimaze, Actiq, Duragesic, Abstral, Subsys, and Ionsys'], 'description': 'Synthetic opioid drug used as an analgesic.', 'armGroupLabels': ['Ketamine Group', 'Propofol Group']}, {'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'General Anesthetic. N-methyl-D-aspartate (NMDA) receptor agonist', 'armGroupLabels': ['Ketamine Group']}, {'name': 'Propofol injection', 'type': 'DRUG', 'otherNames': ['2,6-diisopropylphenol; Diprivan'], 'description': 'General Anesthetic. GABA receptor modulator and calcium channel blocker', 'armGroupLabels': ['Propofol Group']}, {'name': 'Nitrous oxide', 'type': 'DRUG', 'otherNames': ['Nitrous, laughing gas'], 'description': 'Modulates a wide range of ligand-gated ion channels and inhibits NMDA receptor-mediated currents', 'armGroupLabels': ['Ketamine Group', 'Propofol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'NYCHHC - Jacobi Medical Center and North Central Bronx Hospital', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Stephen S Gelfman, MD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York City Health and Hospitals (NYCHHC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}