Clinical trial NCT02733757: Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Keywords: Clonidine
Sub-Tenon's and Peribulbar block
IOP
OPP
OPA
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Federal University of Espirito Santo
First posted: 2016-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Within 10 minutes before the surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Espírito Santo, Vitória
name: Sigmar Cabral, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais, Belo Horizonte
name: Renato Gomez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.