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| Name | Class |
|---|---|
| Federal University of Espirito Santo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Tenon's group control | No Intervention | 2% Lidocaine without epinephrine | |
| Sub-Tenon's group clonidine | Experimental | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg |
|
| Peribulbar group control | No Intervention | 2% Lidocaine without epinephrine | |
| Peribulbar group clonidine | Experimental | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | Clonidine 1 µg/kg plus 2% lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Within 10 minutes before the surgery procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigmar Cabral, PhD | Federal University of Espírito Santo, Vitória | Principal Investigator |
| Renato Gomez, PhD | Federal University of Minas Gerais, Belo Horizonte | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11524193 | Background | 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. | |
| 11423451 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sub-Tenon's Group Control | 2% Lidocaine without epinephrine |
| FG001 | Sub-Tenon's Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine |
| FG002 | Peribulbar Group Control | 2% Lidocaine without epinephrine |
| FG003 | Peribulbar Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sub-Tenon's Group Control | 2% Lidocaine without epinephrine |
| BG001 | Sub-Tenon's Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure (IOP) | Posted | Mean | Standard Deviation | mmHg | Within 10 minutes before the surgery procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sub-Tenon's Group Control | 2% Lidocaine without epinephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Renato Gomez | Universidade federal de Minas Gerais | 553134099760 | renatogomez2000@yahoo.com.br |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 23797624 | Background | 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. |
| BG002 | Peribulbar Group Control | 2% Lidocaine without epinephrine |
| BG003 | Peribulbar Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 |
| Peribulbar Group Clonidine |
2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sub-Tenon's Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine | 0 | 20 | 0 | 20 |
| EG002 | Peribulbar Group Control | 2% Lidocaine without epinephrine | 0 | 20 | 0 | 20 |
| EG003 | Peribulbar Group Clonidine | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine | 0 | 20 | 0 | 20 |
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| D006571 |
| Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |