Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2
Condition: Diabetes Mellitus; Local Anesthesia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): L+C maxillary anesthesia; L+C mandibular anesthesia; L+E maxillary anesthesia; L+E mandibular anesthesia
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml); Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml); Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000); Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care