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

NCT ID: NCT02733757

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sub-Tenon's group control

2% Lidocaine without epinephrine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sub-Tenon's group clonidine

2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Group Type: EXPERIMENTAL

Clonidine

Intervention Type: DRUG

Clonidine 1 µg/kg plus 2% lidocaine

Peribulbar group control

2% Lidocaine without epinephrine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peribulbar group clonidine

2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Group Type: EXPERIMENTAL

Clonidine

Intervention Type: DRUG

Clonidine 1 µg/kg plus 2% lidocaine

Interventions

Clonidine

Clonidine 1 µg/kg plus 2% lidocaine

Intervention Type: DRUG

Other Intervention Names

Atensine

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Espirito Santo

OTHER

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Renato Santiago Gomez

Head of surgery department of the medical school of the Federal University of Minas Gerais

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sigmar Cabral, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Espírito Santo, Vitória

Renato Gomez, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais, Belo Horizonte

References

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.

Reference Type: BACKGROUND

PMID: 11524193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11423451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23797624 (View on PubMed)

Other Identifiers

CAAE - 03409512.2.0000.5149

Identifier Type: -

Identifier Source: org_study_id