Assessment of the Effect of Clonidine for Cataract Surgery
|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.
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 firstname.lastname@example.org|
|Principal Investigator: Ana Ellen Santiago, investigator|
|Study Chair:||Rioko K Sakata, Study Chair||Federal University of Sao Paulo|