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Assessment of the Effect of Clonidine for Cataract Surgery

Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01677351
Enrollment
40
Registered
2012-09-03
Start date
2011-07-31
Completion date
2012-12-31
Last updated
2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Pain

Keywords

clonidine, cataract surgery, arrythmia, anesthesic medication

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®.

Interventions

DRUGClonidine

4 mcg.kg-1, 20 minutes before cataract surgery

DRUGplacebo

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* cataract surgery * topical anesthesia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
intensity of pain30 minutes before surgery, during the surgeryPain intensity will be assessed by numeric rating scale.

Secondary

MeasureTime frameDescription
intraocular pressure30 minutes and during the surgeryIntra-ocular pressure will be assessed with a manual tonometer of perkins.

Other

MeasureTime frameDescription
antiarrythmic effect30 minutes before surgery and during the surgeryThe antiarrythmic effect will be assessed with the continuous measure by Holter.
blood pressure30 minutes before and during the surgeryBlood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026