A Sequential Allocation Study to Determine the ED50 of Dexmetedomidine as an Adjuvant to Lidocaine Intravenous Regional Anesthesia

NCT05342870 | Completed

• 1 other identifier: ANES.CZ.01
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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), the investigators hypothesize that a lower DEX dose would provide patients with adequate anesthesia. 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. 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 patient 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. 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. This study will help determine the ED50 of DEX used as an adjuvant in IVRA. Based on the potency ratios of Clonidine vs. DEX, the investigators 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.

Conditions

Bier Block; Dexmedetomidine; Tourniquet Pain; Carpal Tunnel; Tendon Release; Tendn Transfer

Outcome Measures

Primary Outcomes (1)

• Median effective dose of dexmedetomidine

  The dexmedetomidine dose for the first patient was 0.5 µg/kg, the minimum tourniquet time chosen for our study was 50 minutes. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients. The mean and standard deviation of the ED50 of dexmedetomidine were calculated using the modified up-and-down method, which uses the average dexmedetomidine dose of all independent pairs of patients involved a crossover to calculate the ED50

  During the procedure

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Following a sequential allocation scheme, the dexmedetomidine dose for each patient was determined by the Dixon up-and-down method. The dexmedetomidine dose for the first patient was 0.5 µg/kg. The dose was then adjusted in 0.1 µg/kg increments for the following patients depending on the success of the previous patient's block. If a patient experienced tourniquet pain prior to T0 + 50 minutes the next patient received a higher dose. If a patient did not experience pain at T0 + 50 minutes of tourniquet time the dose for the following patient was decreased. Identical syringes containing the solution mix were prepared by the principal investigator and handed to the blinded anesthesiologist in the room. Stopping rules were set at 6 independent crossovers in the same direction (no pain to pain or pain to no pain), with a minimum number of 20 patients

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 to 70 years of age, ASA physical status I-II, undergoing unilateral hand or forearm surgery (that require 30 minutes or more) under IVRA.

You may not qualify if:

• 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., Weight greater than 100Kg.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Related Publications (1)

• Karam C, Al Assadi S, Kanazi G, Zeeni C. A sequential allocation study to determine the ED50 of Dexmedetomidine as an adjuvant to lidocaine intravenous regional anesthesia. BMC Anesthesiol. 2022 May 27;22(1):165. doi: 10.1186/s12871-022-01702-9.

  PMID: 35624418 DERIVED

MeSH Terms

Conditions

Median Neuropathy

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking Details: This is one arm non-randomized approach. Since it is a sequential approach of medication administration, the anesthesiologist and patients were blinded to whatever dose was given.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share