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

NCT04304157 | Completed Phase 4

• 1 other identifier: ossamahamdyresearch5
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intravenous Drug Usage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in mean blood pressure in mmHg

  8 h ours

• changes in heart rate (beat per minute)

  8 hours

Study Arms (2)

satisfactory

EXPERIMENTAL

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

unsatisfactory

EXPERIMENTAL

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

Interventions

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

Also known as: dixon's sequential method

satisfactory; unsatisfactory

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead
• Tanta University: collaborator

Study Sites (1)

South Valley University

Qina, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gad s Gad, MD

  South Valley University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 11, 2020
• Study Start: August 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: March 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)