Assessment of the Effect of Clonidine for Cataract Surgery
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Arrythmia
Intervention: Clonidine (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Rioko K Sakata, Study Chair, Study Chair, Affiliation: Federal University of Sao Paulo
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.
Clinical Details
Official title: Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: intensity of pain
Secondary outcome: intraocular pressure
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
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- cataract surgery
- topical anesthesia
Exclusion Criteria:
- myocardial ischemia
- psychiatric disease
- chronic pain
- drugs dependency
- use of beta-blockage channel drugs
Locations and Contacts
Federal University of Sao Paulo, Sao Paulo, Brazil; Recruiting Ana Ellen Santiago, investigator, Phone: 55 1 69 9334 4747, Email: ellensantiago@hotmail.com Ana Ellen Santiago, investigator, Principal Investigator
Additional Information
Starting date: July 2011
Last updated: August 31, 2012
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