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

Federal University of Minas Gerais

Status and phase: Completed; Phase 2

Conditions: Anesthesia

Treatments: Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02733757

CAAE - 03409512.2.0000.5149

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 30 to 86 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

Sub-Tenon's group control

No Intervention group

Description:

2% Lidocaine without epinephrine

Sub-Tenon's group clonidine

Experimental group

Description:

2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Treatment:

Drug: Clonidine

Peribulbar group control

No Intervention group

Description:

2% Lidocaine without epinephrine

Peribulbar group clonidine

Experimental group

Description:

2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Treatment:

Drug: Clonidine