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AnesthesiaPhase 4NCT03255824

A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation

A Phase 4 study testing Dexmedetomidine and Midazolam and Propofol, Midazolam, and Fentanyl in people with Anesthesia, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Dexmedetomidine and Midazolam and Propofol, Midazolam, and Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
20 Mar 2018to 27 Dec 2019
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

About this study

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.

Read the detailed description

Intravenous sedation (IVS) is an integral aspect of the oral and maxillofacial surgeon's practice. For many minor oral surgical procedures, intravenous sedation is often necessary to manage patient anxiety and discomfort, while also facilitating a safe and efficient procedure in the outpatient setting. Ideally, sedative agents have anxiolytic, amnestic, and analgesic properties while maintaining cardiopulmonary stability. The medications used should allow for rapid onset of action, as well as a quick recovery, with minimal side effects.

Several pharmacologic agents are frequently used for conscious sedation in the oral surgery practice. These medications often include midazolam, fentanyl, ketamine and propofol, either alone or in conjunction with one another. While propofol and fentanyl have proved to be efficacious agents for use in intravenous sedation, they are not without associated side effects. Propofol has the potential to cause a quick progression from conscious sedation to general anesthesia, with the undesired effect of associated cardiovascular and respiratory depression. Decreased respiratory drive, hypotension, and dose-dependent bradycardia are often seen with opioid analgesics such as fentanyl.1,2 Ketamine can cause emergence delirium, increased salivation and pulmonary secretions, tachycardia, and post-operative nausea and vomiting (PONV).

Midazolam is a benzodiazepine that is an attractive agent for intravenous sedation due to its sedative, amnestic, and hypnotic properties. In addition, it is associated with very minimal cardiovascular and respiratory changes. However, midazolam lacks significant analgesic effects, and therefore is routinely used in conjunction with additional agents when used for procedural sedation. Though several studies have explored the use of midazolam as a sole anesthetic, very high doses are required for deep sedation. This can lead to dose-dependent respiratory depression, prolonged emergence and longer recovery time.

Dexmedetomidine (Precedex, Hospira, Inc., Lake Forest, IL) is a highly selective alpha2-adrenergic agonist that possesses hypnotic, sedative, anxiolytic, and analgesic properties. It is currently approved for use as a sedative agent in ICU patients, and has been proven a safe and effective agent for use during procedural sedation. In the central nervous system, the primary site of action of dexmedetomidine is the locus ceruleus, resulting in a level of sedation similar to natural sleep, associated with fast and easy arousal. It demonstrates relative hemodynamic stability with little effect on respiratory depression. Unlike propofol and fentanyl, dexmedetomidine's lack of adverse effects on respiration makes it an attractive agent for use during intravenous sedation in the oral and maxillofacial surgery practice.

Several studies involving dexmedetomidine exist in the oral and maxillofacial surgery literature. Dexmedetomidine has been compared as a substitute for midazolam, as well as propofol, in conscious sedation by several authors. For third molar surgery, dexmedetomidine was noted to preserve the respiratory rate and oxygen saturation throughout operation and recovery periods. Fan et al also found no significant differences in respiratory rate when comparing the two agents for conscious sedation. In comparison to midazolam, Ryu et al reported safe sedation without airway compromise and minimal effects on the respiratory system.

Dexmedetomidine also possesses sympatholytic properties, and is commonly associated with a dose-dependent decrease in both heart rate and blood pressure.4,9 Taniyama et al compared dexmedetomidine to propofol for intravenous sedation for minor oral surgical procedures. They found that dexmedetomidine lead to significant hemodynamic changes during the initial loading infusion. An initial increase in blood pressure was seen, followed by a significant decrease in both systolic and diastolic blood pressure, as well as heart rate. These variations are attributed to the fact that dexmedetomidine does not have selectivity for alpha-2A versus alpha-2B receptors. While alpha-2A receptors are found in the CNS and are therefore responsible for the analgesic and sedative effects of the drug, alpha-2B receptors are found in vascular smooth muscle and thereby mediate the hypertensive effects of high doses of dexmedetomidine. Because of this, initial loading doses of dexmedetomidine may be associated with a transient increase in blood pressure, followed by an overall reduction in blood pressure and heart rate from baseline. Hall et al reported that dexmedetomidine demonstrated a decrease in heart rate from baseline between 16 and 18%, and a decrease in blood pressure of 10 to 20%.15 However, in some studies, similar biphasic changes were not observed, possibly due to the use of a lower dosage of dexmedetomidine.

Aside from dose-dependent depression of the cardiovascular system, dexmedetomidine has been associated with minimal to no amnesic effects. One other possible disadvantage of dexmedetomidine as a sedative agent for in-office procedures is the increased postoperative recovery time. Peak sedative effects of the drug occur approximately 90-105 minutes after administration, continuing to as much as 180 minutes. This may necessitate post-operative observation periods of increased duration. Intravenously administered dexmedetomidine has a distribution half-life of 6 minutes and an elimination half-life of 2 hours. It undergoes biotransformation in the liver and is excreted primarily in the urine.

The purpose of this study is to measure the relative efficacy (sedation, analgesia, operating conditions, and patient satisfaction) and safety (hemodynamic and respiratory changes) of dexmedetomidine and midazolam compared to the traditional combination of midazolam, fentanyl, and propofol in office based intravenous sedation for extraction of third molars.

Conditions
Anesthesia
Being tested
Dexmedetomidine and Midazolam, Propofol, Midazolam, and Fentanyl
Keywords
Oral Surgery, Third Molars, Intravenous Sedation, Dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine and MidazolamDrug

    Also called Precedex

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

  • Propofol, Midazolam, and FentanylDrug

    Also called Diprivan

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

Study groups in NCT03255824
Study groupRoleWhat they receive
Propofol GroupActive comparatorGroup of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.
Receives: Drug: Propofol, Midazolam, and Fentanyl
Dexmedetomidine GroupExperimentalGroup of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.
Receives: Drug: Dexmedetomidine and Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During surgery

Secondary outcomes (11)
  1. Reaction to Administration of Local Anesthesia

    To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.

    The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)

    Measured: During the first injection of local anesthesia during surgery

  2. Patient Satisfaction

    Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.

    The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).

    A higher score is a better outcome.

    Measured: 30 minutes following surgery

  3. Surgeon Satisfaction - Survey

    Surgeon satisfaction was measured by the surgeon grading the "Operating Conditions" scale.

    The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good

    Measured: 15 minutes following surgery

  4. Cooperation Scale

    Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)

    Measured: 15 minutes following surgery

  5. Hemodynamic Stability - Heart Rate

    To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)

    1. Change in heart rate (change ≥ 20 BPM)

    Measured: During the procedure, up to 40 minutes

  6. Hemodynamic Stability - Blood Pressure

    To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)

    1. Change in blood pressure (NIBP) (change ≥ 20%) Blood pressure is presented as mean arterial pressure

    Measured: During the procedure, up to 40 minutes

  7. Respiratory Depression - Respiratory Rate

    To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.

    1. Change in respiratory rate (change ≥ 20%)

    Measured: During the procedure, up to 40 minutes

  8. Respiratory Depression - Oxygen Saturation

    To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.

    1. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%

    Measured: During the procedure, up to 40 minutes

  9. Postoperative Recovery Time - Duration of Procedure

    To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.

    1. Duration of procedure will be recorded

    Measured: During the procedure, up to 40 minutes

  10. Postoperative Recovery Time - Ambulation

    To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.

    1. Time to ambulation (to recovery room) will be recorded

    Measured: After the procedure until ambulation, up to 20 minutes

  11. Postoperative Recovery Time - Time to Discharge

    To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.

    1. Time to discharge or "virtual discharge" (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate. ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the "virtual discharge" time

    Measured: After the procedure until discharge, up to 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start20 Mar 2018
  3. Primary completion23 Aug 2019
  4. Study completion27 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03255824
Sponsor's protocol ID
2016-6953
Status last verified
Apr 2020
First submitted
28 Jun 2017
Last updated
13 May 2020
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17052563
  • 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.

    PubMed 15930401
  • 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.

    PubMed 15007891
  • 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.

    PubMed 24377675
  • 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.

    PubMed 9541344
  • 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.

    PubMed 22110884
  • 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.

    PubMed 16916668
  • 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.

    PubMed 23058230
  • 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.

    PubMed 20116712
  • 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.

    PubMed 17924894
  • 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.

    PubMed 21685111
  • Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

    PubMed 10730549
  • 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.

    PubMed 7914737
  • 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.

    PubMed 23497981
  • 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.

    PubMed 24697819

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