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

Condition(s) targeted: Diabetes Mellitus; Local Anesthesia

Intervention: L+C maxillary anesthesia (Procedure); L+C mandibular anesthesia (Procedure); L+E maxillary anesthesia (Procedure); L+E mandibular anesthesia (Procedure)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: University of Belgrade

Official(s) and/or principal investigator(s):
Dragica DM Stojic, DDS, PhD, Principal Investigator, Affiliation: School of Dental Medicine, University of Belgrade
Bozidar M Brkovic, DDS, PhD, Principal Investigator, Affiliation: School of Dental Medicine, University of Belgrade
Marija S Milic, DDS, Principal Investigator, Affiliation: School of Dental Medicine, University of Belgrade

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.

Official title: Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

Duration of intraoral local anesthesia

Intensity of intraoral local anesthesia

Change from baseline in systolic blood pressure at 5 minutes

Change from baseline in systolic blood pressure at 10 minutes

Change from baseline in systolic blood pressure at 15 minutes

Change from baseline in systolic blood pressure at 20 minutes

Change from baseline in systolic blood pressure at 35 minutes

Change from baseline in diastolic blood pressure at 5 minutes

Change from baseline in diastolic blood pressure at 10 minutes

Change from baseline in diastolic blood pressure at 15 minutes

Change from baseline in diastolic blood pressure at 20 minutes

Change from baseline in diastolic blood pressure at 35 minutes

Change from baseline in heart rate at 5 minutes

Change from baseline in heart rate at 10 minutes

Change from baseline in heart rate at 15 minutes

Change from baseline in heart rate at 20 minutes

Change from baseline in heart rate at 35 minutes

Change from baseline in electrocardiogram at 5 minutes

Change from baseline in electrocardiogram at 10 minutes

Change from baseline in electrocardiogram at 15 minutes

Change from baseline in electrocardiogram at 20 minutes

Secondary outcome:

Onset of intraoral local anesthesia

Width of anesthetic field

Postoperative analgesia

Local postoperative complications

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

School of Dental Medicine, University of Belgrade, Belgrade 11000, Serbia

Starting date: June 2013
Last updated: June 10, 2015