Anesthesia
Conditions
Keywords
Clonidine, Sub-Tenon's and Peribulbar block, IOP, OPP, OPA
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.
Interventions
DRUGClonidine
Clonidine 1 µg/kg plus 2% lidocaine
Sponsors
Federal University of Espirito Santo
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 86 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) | Within 10 minutes before the surgery procedure |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sub-Tenon's Group Control 2% Lidocaine without epinephrine | 20 |
| Sub-Tenon's Group Clonidine 2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Clonidine: Clonidine 1 µg/kg plus 2% lidocaine | 20 |
| Peribulbar Group Control 2% Lidocaine without epinephrine | 20 |
| Peribulbar Group Clonidine 2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Clonidine: Clonidine 1 µg/kg plus 2% lidocaine | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Sub-Tenon's Group Control | Sub-Tenon's Group Clonidine | Peribulbar Group Control | Peribulbar Group Clonidine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 13 | 64 years STANDARD_DEVIATION 14 | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 14 Participants | 12 Participants | 51 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 6 Participants | 8 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Intraocular Pressure (IOP)
Time frame: Within 10 minutes before the surgery procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sub-Tenon's Group Control | Intraocular Pressure (IOP) | 18 mmHg | Standard Deviation 3 |
| Sub-Tenon's Group Clonidine | Intraocular Pressure (IOP) | 16 mmHg | Standard Deviation 4 |
| Peribulbar Group Control | Intraocular Pressure (IOP) | 19 mmHg | Standard Deviation 3 |
| Peribulbar Group Clonidine | Intraocular Pressure (IOP) | 16 mmHg | Standard Deviation 4 |