Assessment of the Effect of Clonidine for Cataract Surgery
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Jul 2011
Typical duration for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 3, 2012
August 1, 2012
1.2 years
August 1, 2012
August 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intensity of pain
Pain intensity will be assessed by numeric rating scale.
30 minutes before surgery, during the surgery
Secondary Outcomes (1)
intraocular pressure
30 minutes and during the surgery
Other Outcomes (2)
antiarrythmic effect
30 minutes before surgery and during the surgery
blood pressure
30 minutes before and during the surgery
Study Arms (2)
group 2: clonidine 4mcg.kg
ACTIVE COMPARATORthis group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
Group 1: sterile saline solution
PLACEBO COMPARATORthis group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
Interventions
Eligibility Criteria
You may qualify if:
- cataract surgery
- topical anesthesia
You may not qualify if:
- myocardial ischemia
- psychiatric disease
- chronic pain
- drugs dependency
- use of beta-blockage channel drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (1)
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.
PMID: 25276415DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rioko K Sakata, Study Chair
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical resident, principal investigator
Study Record Dates
First Submitted
August 1, 2012
First Posted
September 3, 2012
Study Start
July 1, 2011
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
September 3, 2012
Record last verified: 2012-08