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Assessment of the Effect of Clonidine for Cataract Surgery

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677351

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
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):
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    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Ana Ellen de Queiroz Santiago, Federal University of São Paulo:
cataract surgery
anesthesic medication

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action