Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia

Study Overview
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Brief Summary
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Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.

Detailed Description
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In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded.

Official Title
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Effects of Clonidine Added to Lidocaine in Sub-Tenon's and Peribulbar Anesthesia: Assessments of Intraocular Pressure (IOP), Ocular Perfusion Pressure (OPP) and Ocular Pulse Amplitude (OPA)

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Clonidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 30 and 86 years old Both genders Physical status ASA (American Society of Anesthesiologists) I and II Cooperative patients undergoing cataract surgery by phacoemulsification Exclusion Criteria: Patients with communication difficulties Allergic to any medication protocol Chronic therapy with clonidine In use of antihypertensive medication Diabetes Glaucoma Previous surgery in the same eye Abnormalities in coagulation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sub-Tenon's group control<br>2% Lidocaine without epinephrine | |
| Experimental: Sub-Tenon's group clonidine<br>2% Lidocaine without epinephrine plus clonidine 1 µg/kg | Drug: Clonidine<br>* Clonidine 1 µg/kg plus 2% lidocaine<br>* Other names: Atensine;|
| No Intervention: Peribulbar group control<br>2% Lidocaine without epinephrine | |
| Experimental: Peribulbar group clonidine<br>2% Lidocaine without epinephrine plus clonidine 1 µg/kg | Drug: Clonidine<br>* Clonidine 1 µg/kg plus 2% lidocaine<br>* Other names: Atensine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) |  | Within 10 minutes before the surgery procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonidine, Sub-Tenon's and Peribulbar block, IOP, OPP, OPA