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Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2 (LCIOADMT2)

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ClinicalTrials.gov Identifier: NCT02371759
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade

Brief Summary:
The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Local Anesthesia Drug: L+C maxillary anesthesia Drug: L+C mandibular anesthesia Drug: L+E maxillary anesthesia Drug: L+E mandibular anesthesia Phase 3

Detailed Description:

Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.

Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.

With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diabetics: L+C maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Drug: L+C maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

Experimental: Diabetics: L+C mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Drug: L+C mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

Active Comparator: Diabetics: L+E maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Drug: L+E maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Active Comparator: Diabetics: L+E mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
Drug: L+E mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Experimental: Healthy: L+C maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia
Drug: L+C maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

Experimental: Healthy: L+C mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia
Drug: L+C mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)

Active Comparator: Healthy: L+E maxillary anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia
Drug: L+E maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Active Comparator: Healthy: L+E mandibular anesthesia
Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia
Drug: L+E mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)




Primary Outcome Measures :
  1. Duration of Intraoral Local Anesthesia [ Time Frame: Up to 6 hours after local anesthesia injection ]
    Time until cessation in soft tissue numbness

  2. Intensity of Intraoral Local Anesthesia [ Time Frame: Up to 10 minutes after local anesthesia injection ]
    Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words "no pain" , while the other end is marked with 100 and words "the worst pain imanginable". VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to "no pain", and 10 corresponds to "the worst pain imaginable". For both scales, higher scores represent worse outcomes.

  3. Baseline Systolic Blood Pressure [ Time Frame: Baseline, 0 minutes ]
  4. Systolic Blood Pressure at 10 Minutes [ Time Frame: 10th minute ]
    Systolic blood pressure values 5 minutes after local anesthesia injection

  5. Systolic Blood Pressure at 15 Minutes [ Time Frame: 15th minute ]
    Systolic blood pressure values 10 minutes after local anesthesia injection

  6. Systolic Blood Pressure at 20 Minutes [ Time Frame: 20th minute ]
    Systolic blood pressure values 15 minutes after local anesthesia injection

  7. Systolic Blood Pressure at 35 Minutes [ Time Frame: 35th minute ]
    Systolic blood pressure values 30 minutes after local anesthesia injection

  8. Baseline Diastolic Blood Pressure [ Time Frame: baseline, 0 minutes ]
  9. Diastolic Blood Pressure at 10 Minutes [ Time Frame: 10th minute ]
    Diastolic blood pressure values 5 minutes after local anesthesia injection

  10. Diastolic Blood Pressure at 15 Minutes [ Time Frame: 15th minute ]
    Diastolic blood pressure values 10 minutes after local anesthesia injection

  11. Diastolic Blood Pressure at 20 Minutes [ Time Frame: 20th minute ]
    Diastolic blood pressure values 15 minutes after local anesthesia injection

  12. Diastolic Blood Pressure at 35 Minutes [ Time Frame: 35th minute ]
    Diastolic blood pressure values 30 minutes after local anesthesia injection

  13. Baseline Values of Heart Rate [ Time Frame: baseline, 0 minutes ]
  14. Heart Rate at 10 Minutes [ Time Frame: 10th minute ]
    Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

  15. Heart Rate at 15 Minutes [ Time Frame: 15th minute ]
    Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

  16. Heart Rate at 20 Minutes [ Time Frame: 20th minute ]
    Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement

  17. Ceart Rate at 35 Minutes [ Time Frame: 35th minute ]
    Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement

  18. Baseline Electrocardiogram [ Time Frame: baseline, 0 minutes ]
  19. Electrocardiogram at 10 Minutes [ Time Frame: 10th minute ]
    ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement

  20. Electrocardiogram at 15 Minutes [ Time Frame: 15th minute ]
    ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement

  21. Electrocardiogram at 20 Minutes [ Time Frame: 20th minute ]
    ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement


Secondary Outcome Measures :
  1. Onset of Intraoral Local Anesthesia [ Time Frame: Up to 10 minutes, until subjective feeling of soft tissue numbnes ]
    Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection

  2. Width of Anesthetic Field After Maxillary Infiltration Anesthesia [ Time Frame: Up to 10 minutes after injection of local anesthesia ]
    Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.

  3. Postoperative Analgesia [ Time Frame: up to 24 hours after tooth extraction ]
    Number of participants who experienced postoperative pain, VAS, NRS

  4. Local Postoperative Complications [ Time Frame: 24 hours, 7 days ]
    Postoperative paresthesia by clinical examination



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy participants: ASA I
  • Diabetic type 2 participants: ASA III (HbA1c level < 9%)
  • Required a single-root teeth indicated for non-complicated extraction
  • Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection
  • Subjects give informed written consent

Exclusion Criteria:

  • Pregnancy and lactation
  • Allergy to used drugs and food
  • Hepatic and/or renal failure
  • ASA IV patients
  • Tobacco smokers
  • History of alcoholism and/or drug abuse and addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371759


Locations
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Serbia
School of Dental Medicine, University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Investigators
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Principal Investigator: Dragica DM Stojic, DDS, PhD School of Dental Medicine, University of Belgrade
Principal Investigator: Bozidar M Brkovic, DDS, PhD School of Dental Medicine, University of Belgrade
Principal Investigator: Marija S Milic, DDS School of Dental Medicine, University of Belgrade
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Responsible Party: Bozidar Brkovic, DDS, MSc, PhD, Professor, Professor, DDS, MSc, PhD, University of Belgrade
ClinicalTrials.gov Identifier: NCT02371759    
Other Study ID Numbers: UBelgrade 534/2
175021 ( Other Grant/Funding Number: Ministry of Education, Science and Technological Development )
First Posted: February 26, 2015    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs