Assessment of the Effect of Clonidine for Cataract Surgery

• ClinicalTrials.gov Identifier: NCT01677351
• Recruitment Status: Unknown
• First Posted: September 3, 2012
• Last Update Posted: September 3, 2012
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Ana Ellen de Queiroz Santiago, Federal University of São Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Arrythmia	Drug: Clonidine; Drug: placebo	Phase 2

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®.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery
• Study Start Date: July 2011
• Estimated Primary Completion Date: September 2012
• Estimated Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: group 2: clonidine 4mcg.kg; this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.	Drug: Clonidine; 4 mcg.kg-1, 20 minutes before cataract surgery; Other Names: cataract surgery; anesthesic drugs
Placebo Comparator: Group 1: sterile saline solution; this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery	Drug: placebo

Outcome Measures

Primary Outcome Measures :

1. intensity of pain [ Time Frame: 30 minutes before surgery, during the surgery ]
   Pain intensity will be assessed by numeric rating scale.

Secondary Outcome Measures :

1. intraocular pressure [ Time Frame: 30 minutes and during the surgery ]
   Intra-ocular pressure will be assessed with a manual tonometer of perkins.

Other Outcome Measures:

1. antiarrythmic effect [ Time Frame: 30 minutes before surgery and during the surgery ]
   The antiarrythmic effect will be assessed with the continuous measure by Holter.
2. blood pressure [ Time Frame: 30 minutes before and during the surgery ]
   Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• cataract surgery
• topical anesthesia

Exclusion Criteria:

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

Contacts and Locations

Locations

Brazil

Federal University of Sao Paulo; Recruiting

Sao Paulo, Brazil

Contact: Ana Ellen Santiago, investigator 55 1 69 9334 4747 ellensantiago@hotmail.com

Principal Investigator: Ana Ellen Santiago, investigator

Sponsors and Collaborators

Federal University of São Paulo

Investigators

• Study Chair: Rioko K Sakata, Study Chair; Federal University of Sao Paulo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ana Ellen de Queiroz Santiago, medical resident, principal investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01677351 History of Changes
• Other Study ID Numbers: CEP 0609/01-clonidine
• First Posted: September 3, 2012
• Last Update Posted: September 3, 2012
• Last Verified: August 2012

Keywords provided by Ana Ellen de Queiroz Santiago, Federal University of São Paulo:

clonidine; cataract surgery; arrythmia; anesthesic medication

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases; Clonidine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action