Median Effective Dose of Dexmedetomidine in Elective Upper Limb Lidocaine Intravenous Regional Anesthesia (dexdix)

A Prospective, Double Masked, up and Down Sequential Method to Estimate the Median Effective Dose of Dexmedetomidine in Elective Upper Limb Lidocaine Intravenous Regional Anesthesia

Auxiliary drugs augment the effect of local anesthetic in intravenous regional anesthesia (IVRA). The purpose of our study was to estimate the median effective dose (ED50) of Dexmedetomidine in elective upper limb Lidocaine 0.5% IVRA.

Study Overview

• Status: Completed
• Conditions: Intravenous Drug Usage
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Since its innovation in 1908 by Dr August Bier of Germany, Intravenous regional anesthesia (IVRA) has stood the test of time as simple, safe and effective technique of regional anesthesia. 1 The technique entails insertion of intravenous catheter into a surgical limb before isolating it from the general circulation by tourniquet then inject local anesthetic (LA) into this isolated limb. 2 IVRA block is preferably used with short surgical procedures or maneuvers of the upper or lower extremity. Nevertheless, the technique has gained popularity for procedures of the upper extremity because of tourniquet issues like tourniquet pain, and other safety concerns that arise more often with lower extremity IVRA, essentially leakage of the of LA.3 Unfortunately, using LA solely for IVRA has not achieved optimum intraoperative analgesia or overcome the frequently reported tourniquet pain.4 A long list of adjuvants, to mention few: morphine, muscle relaxant and clonidine, have been used to augment LA action and ameliorate tourniquet pain. 5 Dexmedetomidine (DEX) a potent α 2 agonist that have unique analgesic, anxiolytic and sedative profile has been called upon as attractive adjunct in general as well as regional anesthesia with enticing results. Several studies have pursued DEX median effective dose (ED50) in different settings e.g., co induction agent with Propofol, in laryngeal muscle insertion and with local anesthetic to enhance the quality of spinal anesthesia. 6 However, DEX effective median dose ED50 with IVRA for upper limb has not been investigated elsewhere, so far. The up and down sequential method of Dixon and Mood is a common sequential design method used in anesthesia research to detect the ED50. It is a sequence of experiments performed under the assumption that "satisfactory response" is followed by decrease in test dose for the next patient in the series, and "non- satisfactory response" is followed by increase in test dose for the next patient in the series. 7 The purpose of this study is to estimate the median effective dose of Dexmedetomidine (DEX) with Lidocaine 0.5% IVRA in upper limb elective surgeries, using modified Dixon's up and down method.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged between 18 and 60 years
• American Society of Anesthesiologists physical status I or II
• Undergoing minor upper limb orthopedic surgical procedures in the hand, wrist and forearms including: metacarpal fracture, tendon injury, and carpal tunnel release.

Exclusion Criteria:

• Allergy to test drugs.
• vascular disease.
• contraindication to tourniquet applications.
• difficulty to manipulate the surgical limb.
• surgery expected to last more than an hour.
• patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: satisfactory; 0.4 µg.kg of dexmedetomidine, with 0.1 µg.kg dose interval. If IVRA outcome was satisfactory, the dose went down for the next patient by 0.1 µg.kg. Vice versa, if the outcome was unsatisfactory, the dexmedetomidine dose was stepped up by 0.1 µg.kg for the following patient	Drug: Dexmedetomidine; Dexmedetomidine (DEX) a potent α 2 agonist that have unique analgesic, anxiolytic and sedative profile has been called upon as attractive adjunct in general as well as regional anesthesia with enticing results. Several studies have pursued DEX median effective dose (ED50) in different settings e.g., co induction agent with Propofol, in laryngeal muscle insertion and with local anesthetic to enhance the quality of spinal anesthesia; Other Names: dixon's sequential method
Experimental: unsatisfactory; 0.4 µg.kg of dexmedetomidine, with 0.1 µg.kg dose interval. If IVRA outcome was satisfactory, the dose went down for the next patient by 0.1 µg.kg. Vice versa, if the outcome was unsatisfactory, the dexmedetomidine dose was stepped up by 0.1 µg.kg for the following patient	Drug: Dexmedetomidine; Dexmedetomidine (DEX) a potent α 2 agonist that have unique analgesic, anxiolytic and sedative profile has been called upon as attractive adjunct in general as well as regional anesthesia with enticing results. Several studies have pursued DEX median effective dose (ED50) in different settings e.g., co induction agent with Propofol, in laryngeal muscle insertion and with local anesthetic to enhance the quality of spinal anesthesia; Other Names: dixon's sequential method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Pain intensity measure	Patients reported pain intensity at baseline, every 5 minutes during the surgery and every hour for 6 hours after the surgery. Pain intensity scored 0-10 (0 being no pain at all, and 10 the worst pain ever).	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean blood pressure in mmHg	mean blood pressure in mmHg was measured at baseline, every 5 minutes during the surgery and every hour for 6 hours after the surgery	8 h ours
changes in heart rate (beat per minute)	Changes in heart at baseline, every 5 minutes during the surgery and every hour for 6 hours after the surgery	8 hours

Collaborators and Investigators

• Sponsor: South Valley University
• Collaborators: Tanta University
• Investigators: Study Director: Gad s Gad, MD, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 7, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: ossamahamdyresearch5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No