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

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)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Clonidine

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Federal University of Espirito Santo
• Investigators: Principal Investigator: Sigmar Cabral, PhD, Federal University of Espírito Santo, Vitória; Study Director: Renato Gomez, PhD, Federal University of Minas Gerais, Belo Horizonte

Publications and helpful links

General Publications

• Pianka P, Weintraub-Padova H, Lazar M, Geyer O. Effect of sub-Tenon's and peribulbar anesthesia on intraocular pressure and ocular pulse amplitude. J Cataract Refract Surg. 2001 Aug;27(8):1221-6. doi: 10.1016/s0886-3350(01)00797-0.
• Watkins R, Beigi B, Yates M, Chang B, Linardos E. Intraocular pressure and pulsatile ocular blood flow after retrobulbar and peribulbar anaesthesia. Br J Ophthalmol. 2001 Jul;85(7):796-8. doi: 10.1136/bjo.85.7.796.
• Cabral SA, Carraretto AR, Brocco MC, Abreu Baptista JF, Gomez RS. Effect of clonidine added to lidocaine for sub-Tenon's (episcleral) anesthesia in cataract surgery. J Anesth. 2014 Feb;28(1):70-5. doi: 10.1007/s00540-013-1660-2.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: IOP; Clonidine; OPA; Sub-Tenon's and Peribulbar block; OPP
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: CAAE - 03409512.2.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED