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
|Condition or disease||Intervention/treatment||Phase|
|Pain Arrythmia||Drug: Clonidine Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: group 2: clonidine 4mcg.kg
this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
4 mcg.kg-1, 20 minutes before cataract surgery
Placebo Comparator: Group 1: sterile saline solution
this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
- intensity of pain [ Time Frame: 30 minutes before surgery, during the surgery ]Pain intensity will be assessed by numeric rating scale.
- intraocular pressure [ Time Frame: 30 minutes and during the surgery ]Intra-ocular pressure will be assessed with a manual tonometer of perkins.
- 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.
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 email@example.com|
|Principal Investigator: Ana Ellen Santiago, investigator|
|Study Chair:||Rioko K Sakata, Study Chair||Federal University of Sao Paulo|