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Trial record 40 of 331 for:    clonidine

Assessment of the Effect of Clonidine for Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Ana Ellen de Queiroz Santiago, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE September 3, 2012
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
intensity of pain [ Time Frame: 30 minutes before surgery, during the surgery ]
Pain intensity will be assessed by numeric rating scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
intraocular pressure [ Time Frame: 30 minutes and during the surgery ]
Intra-ocular pressure will be assessed with a manual tonometer of perkins.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2012)
  • antiarrythmic effect [ Time Frame: 30 minutes before surgery and during the surgery ]
    The antiarrythmic effect will be assessed with the continuous measure by Holter.
  • blood pressure [ Time Frame: 30 minutes before and during the surgery ]
    Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of Clonidine for Cataract Surgery
Official Title  ICMJE Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Arrythmia
Intervention  ICMJE
  • Drug: Clonidine
    4 mcg.kg-1, 20 minutes before cataract surgery
    Other Names:
    • cataract surgery
    • anesthesic drugs
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: group 2: clonidine 4mcg.kg
    this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
    Intervention: Drug: Clonidine
  • Placebo Comparator: Group 1: sterile saline solution
    this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • cataract surgery
  • topical anesthesia

Exclusion Criteria:

  • myocardial ischemia
  • psychiatric disease
  • chronic pain
  • drugs dependency
  • use of beta-blockage channel drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01677351
Other Study ID Numbers  ICMJE CEP 0609/01-clonidine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Ellen de Queiroz Santiago, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Rioko K Sakata, Study Chair Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP