Clinical trial NCT01677351: Assessment of the Effect of Clonidine for Cataract Surgery
Official title: Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Arrythmia
Keywords: clonidine
cataract surgery
arrythmia
anesthesic medication
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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®.

Eligibility criteria: Inclusion Criteria:

* cataract surgery
* topical anesthesia

Exclusion Criteria:

* myocardial ischemia
* psychiatric disease
* chronic pain
* drugs dependency
* use of beta-blockage channel drugs

Primary outcomes:
measure: intensity of pain
timeFrame: 30 minutes before surgery, during the surgery
Secondary outcomes:
measure: intraocular pressure
timeFrame: 30 minutes and during the surgery
Other outcomes:
measure: antiarrythmic effect
timeFrame: 30 minutes before surgery and during the surgery
measure: blood pressure
timeFrame: 30 minutes before and during the surgery
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rioko K Sakata, Study Chair
role: STUDY_CHAIR
References:
citation: 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.