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

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: Drug: Clonidine

• Registration Number: NCT02733757
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub-Tenon's group clonidine	Clonidine	2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Peribulbar group clonidine	Clonidine	2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	Within 10 minutes before the surgery procedure