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Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias for cataract surgery.
After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40 until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency, chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of 4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will receive a sterile saline solution dose. Pain intensity will be assessed with the numeric rating scale. The antiarrythmic effect will be assessed with the continuous measure by Holter. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 2: clonidine 4mcg.kg | Active Comparator | this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery. |
|
| Group 1: sterile saline solution | Placebo Comparator | this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | 4 mcg.kg-1, 20 minutes before cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| intensity of pain | Pain intensity will be assessed by numeric rating scale. | 30 minutes before surgery, during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | Intra-ocular pressure will be assessed with a manual tonometer of perkins. | 30 minutes and during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| antiarrythmic effect | The antiarrythmic effect will be assessed with the continuous measure by Holter. | 30 minutes before surgery and during the surgery |
| blood pressure | Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rioko K Sakata, Study Chair | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo | Recruiting | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25276415 | Derived | Santiago AE, Issy AM, Sakata RK. Effects of preoperative intravenous clonidine in patients undergoing cataract surgery: a double-blind, randomized trial. J Ophthalmol. 2014;2014:346549. doi: 10.1155/2014/346549. Epub 2014 Sep 2. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| placebo | Drug |
|
| 30 minutes before and during the surgery |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D006571 |
| Heterocyclic Compounds |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |