Study of Use of Dexmedetomidine for Regional Anesthesia

NCT01969903 | Withdrawn Phase 2 DMC

• 1 other identifier: S13-00716
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out the proper amount of a drug called dexmedetomidine added to the local anesthetic drug called lidocaine to prolong the time and effect of pain relief provided for surgery. Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA) and indicated for sedation (calming effect). It has both pain relieving and calming effects when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to lidocaine decreased blood pressure and heart rate. The investigators plan to study the effect of lower amounts of dexmedetomidine to achieve the same level and duration of pain relief without reduction of blood pressure and heart rate.

Conditions

Anesthesia

Keywords

brachial plexus block; lidocaine; dexmedetomidine; bradycardia; hypotension

Outcome Measures

Primary Outcomes (1)

• Pain scores on Visual Analog Scale will be measured

  Heart rate will be monitored continuously and the blood pressure - every 5 min during the entire surgical procedure, because dexmedetomidine can cause bradycardia and hypotension. Participants will be followed for the duration of hospital stay.

Study Arms (3)

No dexmedetomidine injected

EXPERIMENTAL

Control group in which will be used only lidocaine for brachial plexus block

Drug: Precedex injection

0.3 microgs/kg of dexmedetomidine

EXPERIMENTAL

Experimental group, in which 0.3 microgs/kg dexmedetomidine will be added to lidocaine for brachial plexus block

Drug: Precedex injection

0.6 microgs/kg of dexmedeomidine

EXPERIMENTAL

Experimental group, in which 0.6 microgs/kg dexmedetomidine will be added to lidocaine for brachial plexus block

Drug: Precedex injection

Interventions

Precedex injection DRUG

Also known as: precedex

0.3 microgs/kg of dexmedetomidine; 0.6 microgs/kg of dexmedeomidine; No dexmedetomidine injected

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (within the age range described above) of all racial and ethnic origin, accepted to Bellevue Hospital for upper extremity surgeries, will be included in the study. Research will include only subjects who will have regional anesthesia as standard of care.

You may not qualify if:

• The patients with history of hypersensitivity to local anesthetics, hematological diseases, bleeding or coagulation abnormalities, mental impairment, neurologic diseases, unstable cardiac, hepatic, end-stage renal, pulmonary and coagulation abnormality, history of drug abuse will not be included in the study. Vulnerable subjects also will be excluded from the study.
• Patients with baseline heart rate lower than 65 bpm, blood pressure lower than 100/60, and with known allergy to precedex will be excluded from the study. Vulnerable subjects (i.e. children, pregnant women, prisoners, cognitively impaired) will be excluded from the study.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Bradycardia; Hypotension

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 25, 2013
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 8, 2016

Record last verified: 2016-12