NCT03255824

Brief Summary

Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and 3) no significant hemodynamic or respiratory changes when compared to a sedation combination of midazolam, fentanyl and propofol for sedation during third molar surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

May 13, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

June 28, 2017

Results QC Date

March 23, 2020

Last Update Submit

April 28, 2020

Conditions

Anesthesia

Keywords

Oral SurgeryThird MolarsIntravenous SedationDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Respiratory Events Requiring Intervention

    To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.

    During surgery

Secondary Outcomes (11)

  • Reaction to Administration of Local Anesthesia

    During the first injection of local anesthesia during surgery

  • Patient Satisfaction

    30 minutes following surgery

  • Surgeon Satisfaction - Survey

    15 minutes following surgery

  • Cooperation Scale

    15 minutes following surgery

  • Hemodynamic Stability - Heart Rate

    During the procedure, up to 40 minutes

  • +6 more secondary outcomes

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.

Drug: Propofol, Midazolam, and Fentanyl

Dexmedetomidine Group

EXPERIMENTAL

Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.

Drug: Dexmedetomidine and Midazolam

Interventions

Dexmedetomidine and MidazolamDRUG

Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.

Also known as: Precedex
Dexmedetomidine Group
Propofol, Midazolam, and FentanylDRUG

Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.

Also known as: Diprivan
Propofol Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
  • ASA Class I or II
  • English-speaking and Spanish-speaking subjects

You may not qualify if:

  • ASA Class III or higher
  • Patients taking alpha-2 agonists or benzodiazepines
  • Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
  • BMI greater than 30
  • History of or current substance abuse or alcoholism
  • History of mood-altering medications, tranquilizers, or antidepressants.
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (19)

  • Roback MG, Wathen JE, MacKenzie T, Bajaj L. A randomized, controlled trial of i.v. versus i.m. ketamine for sedation of pediatric patients receiving emergency department orthopedic procedures. Ann Emerg Med. 2006 Nov;48(5):605-12. doi: 10.1016/j.annemergmed.2006.06.001. Epub 2006 Aug 14.

    PMID: 17052563BACKGROUND

  • Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009.

    PMID: 15930401BACKGROUND

  • Barone CP, Pablo CS, Barone GW. Postanesthetic care in the critical care unit. Crit Care Nurse. 2004 Feb;24(1):38-45. No abstract available.

    PMID: 15007891BACKGROUND

  • Eberl S, Preckel B, Bergman JJ, Hollmann MW. Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial. BMC Gastroenterol. 2013 Dec 30;13:176. doi: 10.1186/1471-230X-13-176.

    PMID: 24377675BACKGROUND

  • Parworth LP, Frost DE, Zuniga JR, Bennett T. Propofol and fentanyl compared with midazolam and fentanyl during third molar surgery. J Oral Maxillofac Surg. 1998 Apr;56(4):447-53; discussion 453-4. doi: 10.1016/s0278-2391(98)90710-8.

    PMID: 9541344BACKGROUND

  • Jun NH, Shim JK, Choi YS, An SH, Kwak YL. Effect of ketamine pretreatment for anaesthesia in patients undergoing percutaneous transluminal balloon angioplasty with continuous remifentanil infusion. Korean J Anesthesiol. 2011 Oct;61(4):308-14. doi: 10.4097/kjae.2011.61.4.308. Epub 2011 Oct 22.

    PMID: 22110884BACKGROUND

  • Ustun Y, Gunduz M, Erdogan O, Benlidayi ME. Dexmedetomidine versus midazolam in outpatient third molar surgery. J Oral Maxillofac Surg. 2006 Sep;64(9):1353-8. doi: 10.1016/j.joms.2006.05.020.

    PMID: 16916668BACKGROUND

  • Fan TW, Ti LK, Islam I. Comparison of dexmedetomidine and midazolam for conscious sedation in dental surgery monitored by bispectral index. Br J Oral Maxillofac Surg. 2013 Jul;51(5):428-33. doi: 10.1016/j.bjoms.2012.08.013. Epub 2012 Oct 8.

    PMID: 23058230BACKGROUND

  • Makary L, Vornik V, Finn R, Lenkovsky F, McClelland AL, Thurmon J, Robertson B. Prolonged recovery associated with dexmedetomidine when used as a sole sedative agent in office-based oral and maxillofacial surgery procedures. J Oral Maxillofac Surg. 2010 Feb;68(2):386-91. doi: 10.1016/j.joms.2009.09.107.

    PMID: 20116712BACKGROUND

  • Cheung CW, Ying CL, Chiu WK, Wong GT, Ng KF, Irwin MG. A comparison of dexmedetomidine and midazolam for sedation in third molar surgery. Anaesthesia. 2007 Nov;62(11):1132-8. doi: 10.1111/j.1365-2044.2007.05230.x.

    PMID: 17924894BACKGROUND

  • Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.

    PMID: 21685111BACKGROUND

  • Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

    PMID: 10730549BACKGROUND

  • Jaakola ML. Dexmedetomidine premedication before intravenous regional anesthesia in minor outpatient hand surgery. J Clin Anesth. 1994 May-Jun;6(3):204-11. doi: 10.1016/0952-8180(94)90060-4.

    PMID: 7914737BACKGROUND

  • Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.

    PMID: 23497981BACKGROUND

  • Smiley MK, Prior SR. Dexmedetomidine sedation with and without midazolam for third molar surgery. Anesth Prog. 2014 Spring;61(1):3-10. doi: 10.2344/0003-3006-61.1.3.

    PMID: 24697819BACKGROUND

  • Ryu DS, Lee DW, Choi SC, Oh IH. Sedation Protocol Using Dexmedetomidine for Third Molar Extraction. J Oral Maxillofac Surg. 2016 May;74(5):926.e1-7. doi: 10.1016/j.joms.2015.12.021. Epub 2016 Jan 7.

    PMID: 26850877BACKGROUND

  • Taniyama K, Oda H, Okawa K, Himeno K, Shikanai K, Shibutani T. Psychosedation with dexmedetomidine hydrochloride during minor oral surgery. Anesth Prog. 2009 Autumn;56(3):75-80. doi: 10.2344/0003-3006-56.3.75.

    PMID: 19769420BACKGROUND

  • Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.

    PMID: 10702460BACKGROUND

  • Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.

    PMID: 19697008BACKGROUND

MeSH Terms

Interventions

DexmedetomidineMidazolamPropofolFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidines

Results Point of Contact

Title
Dr. Patrick Nolan
Organization
Montefiore Medical Center
pnolan@montefiore.org
718-405-8195

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Oral Maxillofacial Surgery

Study Record Dates

First Submitted

June 28, 2017

First Posted

August 21, 2017

Study Start

March 20, 2018

Primary Completion

August 23, 2019

Study Completion

December 27, 2019

Last Updated

May 13, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)