Clinical trial NCT02371759: Lidocaine + Clonidine for Intraoral 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Local Anesthesia
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Duration of Intraoral Local Anesthesia
timeFrame: Up to 6 hours after local anesthesia injection
measure: Intensity of Intraoral Local Anesthesia
timeFrame: Up to 10 minutes after local anesthesia injection
measure: Baseline Systolic Blood Pressure
timeFrame: Baseline, 0 minutes
measure: Systolic Blood Pressure at 10 Minutes
timeFrame: 10th minute
measure: Systolic Blood Pressure at 15 Minutes
timeFrame: 15th minute
measure: Systolic Blood Pressure at 20 Minutes
timeFrame: 20th minute
measure: Systolic Blood Pressure at 35 Minutes
timeFrame: 35th minute
measure: Baseline Diastolic Blood Pressure
timeFrame: baseline, 0 minutes
measure: Diastolic Blood Pressure at 10 Minutes
timeFrame: 10th minute
measure: Diastolic Blood Pressure at 15 Minutes
timeFrame: 15th minute
measure: Diastolic Blood Pressure at 20 Minutes
timeFrame: 20th minute
measure: Diastolic Blood Pressure at 35 Minutes
timeFrame: 35th minute
measure: Baseline Values of Heart Rate
timeFrame: baseline, 0 minutes
measure: Heart Rate at 10 Minutes
timeFrame: 10th minute
measure: Heart Rate at 15 Minutes
timeFrame: 15th minute
measure: Heart Rate at 20 Minutes
timeFrame: 20th minute
measure: Ceart Rate at 35 Minutes
timeFrame: 35th minute
measure: Baseline Electrocardiogram
timeFrame: baseline, 0 minutes
measure: Electrocardiogram at 10 Minutes
timeFrame: 10th minute
measure: Electrocardiogram at 15 Minutes
timeFrame: 15th minute
measure: Electrocardiogram at 20 Minutes
timeFrame: 20th minute
Secondary outcomes:
measure: Onset of Intraoral Local Anesthesia
timeFrame: Up to 10 minutes, until subjective feeling of soft tissue numbnes
measure: Width of Anesthetic Field After Maxillary Infiltration Anesthesia
timeFrame: Up to 10 minutes after injection of local anesthesia
measure: Postoperative Analgesia
timeFrame: up to 24 hours after tooth extraction
measure: Local Postoperative Complications
timeFrame: 24 hours, 7 days
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine, University of Belgrade
Study officials:
affiliation: School of Dental Medicine, University of Belgrade
name: Dragica DM Stojic, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dental Medicine, University of Belgrade
name: Bozidar M Brkovic, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dental Medicine, University of Belgrade
name: Marija S Milic, DDS
role: PRINCIPAL_INVESTIGATOR
References: