Assessment of the Effect of Clonidine for Cataract Surgery

This study is currently recruiting participants.
Verified August 2012 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Ana Ellen de Queiroz Santiago, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01677351
First received: August 1, 2012
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Pain
Arrythmia
Drug: Clonidine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • intensity of pain [ Time Frame: 30 minutes before surgery, during the surgery ] [ Designated as safety issue: Yes ]
    Pain intensity will be assessed by numeric rating scale.


Secondary Outcome Measures:
  • intraocular pressure [ Time Frame: 30 minutes and during the surgery ] [ Designated as safety issue: Yes ]
    Intra-ocular pressure will be assessed with a manual tonometer of perkins.


Other Outcome Measures:
  • antiarrythmic effect [ Time Frame: 30 minutes before surgery and during the surgery ] [ Designated as safety issue: Yes ]
    The antiarrythmic effect will be assessed with the continuous measure by Holter.

  • blood pressure [ Time Frame: 30 minutes before and during the surgery ] [ Designated as safety issue: Yes ]
    Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677351

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

No publications provided

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
Study First Received: August 1, 2012
Last Updated: August 31, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
clonidine
cataract surgery
arrythmia
anesthesic medication

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cataract
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Lens Diseases
Eye Diseases
Clonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014