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NCT Number: NCT04304157

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Valley University

Qina, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Primary outcomes

  1. 1. Pain intensity measure

    Time frame: 8 hours

    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).

Secondary outcomes

  1. Changes in mean blood pressure in mmHg

    Time frame: 8 h ours

    mean blood pressure in mmHg was measured at baseline, every 5 minutes during the surgery and every hour for 6 hours after the surgery

  2. changes in heart rate (beat per minute)

    Time frame: 8 hours

    Changes in heart at baseline, every 5 minutes during the surgery and every hour for 6 hours after the surgery

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Acronym: dexdix

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2020
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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