- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153123
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before and after peribulbar block with lidocaine in presence or absence of epinephrine.
Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected. Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and 1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 min after the peribulbar block.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130100
- Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I, II or III physical status classification
- Cataract surgery
Exclusion Criteria:
- glaucoma
- diabetic retinopathy
- previous eye surgery in the same eye
- ocular trauma
- allergic to any protocol medication
- uncooperative patients or cognitive difficulties
- axial eye diameter of less than 21.0 mm or greater than 25.5 mm.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lidocaine with epinephrine
Peribulbar anesthesia with lidocaine and epinephrine
|
|
NO_INTERVENTION: Lidocaine without epinephrine
Peribulbar anesthesia with lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Artery resistance index of ophthalmic artery
Time Frame: Change on resistance index 10 minutes after peribulbar anesthesia
|
The resistance index (RI) of OA was evaluated using echo-Doppler before and 10 minutes after the peribulbar block.
|
Change on resistance index 10 minutes after peribulbar anesthesia
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- CAAE 04433113.0.0000.5149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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