Clinical Research Details

Descriptive Information
A sequential allocation study to determine the ED50 of Dexmetedomidine as an adjuvant to Lidocaine Intravenous Regional Anesthesia.

Carine Zeeni
Completed- Has Results

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

Iman Jaafar
Extension: 5612
Conditions and Keywords
hand and forearm surgery,postoperative pain
Bier block, Dexmetedomidine, tourniquet pain, Dixon up-down.
Study Design
Health Services Research
Pharmacokinetics and/or Pharmacodynamics
Double Blind
N/A: Not Applicable
Non- Randomized
N/A: Not Applicable
Eligibility and IRB
Min: 18
Max: 100


Background: Intravenous Regional Anesthesia (IVRA) is an easy and reliable anesthetic technique for hand and forearm surgery. Its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. Many adjuvants to local anesthetics have been studied in order to overcome these shortcomings, including α2 adrenergic agonists. Clonidine has been shown to be efficacious when used with IVRA at a dose of 1µg/kg. Dexmetedomidine (DEX) is a recent more selective α2 adrenergic agonist that has been used successfully during IVRA at a dose of 0.5µg/kg. However when comparing potency ratios of Clonidine and DEX (8 to 1) we hypothesize that a lower DEX dose would provide patients with adequate anesthesia.

                Aim: We will determine the population average dose of DEX (ED50) that provides 50 minutes of tolerance to the tourniquet during a Lidocaine IVRA by a sequential Dixon up-down allocation study.

                Methods: Eligible patients will be enrolled after obtaining informed consent. Patients will receive a standardized IVRA with Lidocaine and DEX adjuvant following a sequential allocation scheme. The first patient will receive a dose of 0.5 µg/kg of DEX. The dose will be then adjusted in 0.1 µg/kg increments for the following patients dependent on the success of the previous patients block. If a patients experiences tourniquet pain prior to 50 minutes after inflation of the distal tourniquet the next patient will receive a higher dose, if he does not experience pain prior to 50 minutes after inflation of the distal tourniquet the dose for the following patient will be decreased.

                Analysis: Recruitment will continue until 6 independent crossovers are observed with a minimum of 20 patients. The mean and the standard deviation of the ED50 of DEX will be calculated using the modified up-down method.

                Significance: This study will help us determine the ED50 of DEX used as an adjuvant in IVRA. Based on the potency ratios of Clonidine vs. DEX we hypothesize that the dose of DEX needed to achieve 50 minutes of pain free tourniquet time will be closer to 0.125 µg/kg rather than 0.5 µg/kg, a 75% reduction in the dose studied.

All eligible patients like you undergoing minor hand and forearm surgery under IVRA at AUB-MC

 Convenient Non random Sampling

 Patients 18 years of age or older, ASA physical status I-II, undergoing unilateral hand or forearm surgery under IVRA.


Patients with Raynaud’s disease, sickle cell anemia, heart block, allergy to any of the anesthetic drugs used, patients on α-adrenergic agonists, ASA III or IV, emergency surgery and pregnant patients.