Assessment of the Effect of Clonidine for Cataract Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01677351
• Other study ID #: CEP 0609/01-clonidine
• Status: Recruiting
• Phase: Phase 2
• First received: August 1, 2012
• Last updated: August 31, 2012
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• cataract surgery

• topical anesthesia

Exclusion Criteria:

• myocardial ischemia

• psychiatric disease

• chronic pain

• drugs dependency

• use of beta-blockage channel drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrythmia
• Cataract
• Pain

Intervention

Drug:
• Clonidine
4 mcg.kg-1, 20 minutes before cataract surgery
• placebo

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	antiarrythmic effect	The antiarrythmic effect will be assessed with the continuous measure by Holter.	30 minutes before surgery and during the surgery	Yes
Other	blood pressure	Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.	30 minutes before and during the surgery	Yes
Primary	intensity of pain	Pain intensity will be assessed by numeric rating scale.	30 minutes before surgery, during the surgery	Yes
Secondary	intraocular pressure	Intra-ocular pressure will be assessed with a manual tonometer of perkins.	30 minutes and during the surgery	Yes