Diabetes Mellitus Clinical Trial
Official title:
Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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