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Assessment of the Effect of Clonidine for Cataract Surgery

Primary Purpose

Pain, Arrythmia

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Clonidine
placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring clonidine, cataract surgery, arrythmia, anesthesic medication

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cataract surgery
  • topical anesthesia

Exclusion Criteria:

  • myocardial ischemia
  • psychiatric disease
  • chronic pain
  • drugs dependency
  • use of beta-blockage channel drugs

Sites / Locations

  • Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group 2: clonidine 4mcg.kg

Group 1: sterile saline solution

Arm Description

this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.

this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery

Outcomes

Primary Outcome Measures

intensity of pain
Pain intensity will be assessed by numeric rating scale.

Secondary Outcome Measures

intraocular pressure
Intra-ocular pressure will be assessed with a manual tonometer of perkins.

Full Information

First Posted
August 1, 2012
Last Updated
August 31, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01677351
Brief Title
Assessment of the Effect of Clonidine for Cataract Surgery
Official Title
Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Arrythmia
Keywords
clonidine, cataract surgery, arrythmia, anesthesic medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 2: clonidine 4mcg.kg
Arm Type
Active Comparator
Arm Description
this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
Arm Title
Group 1: sterile saline solution
Arm Type
Placebo Comparator
Arm Description
this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
cataract surgery, anesthesic drugs
Intervention Description
4 mcg.kg-1, 20 minutes before cataract surgery
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
intensity of pain
Description
Pain intensity will be assessed by numeric rating scale.
Time Frame
30 minutes before surgery, during the surgery
Secondary Outcome Measure Information:
Title
intraocular pressure
Description
Intra-ocular pressure will be assessed with a manual tonometer of perkins.
Time Frame
30 minutes and during the surgery
Other Pre-specified Outcome Measures:
Title
antiarrythmic effect
Description
The antiarrythmic effect will be assessed with the continuous measure by Holter.
Time Frame
30 minutes before surgery and during the surgery
Title
blood pressure
Description
Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.
Time Frame
30 minutes before and during the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cataract surgery topical anesthesia Exclusion Criteria: myocardial ischemia psychiatric disease chronic pain drugs dependency use of beta-blockage channel drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, Study Chair
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Ellen Santiago, investigator
Phone
55 1 69 9334 4747
Email
ellensantiago@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ana Ellen Santiago, investigator

12. IPD Sharing Statement

Citations:
PubMed Identifier
25276415
Citation
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.
Results Reference
derived

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Assessment of the Effect of Clonidine for Cataract Surgery

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