Assessment of the Effect of Clonidine for Cataract Surgery

August 31, 2012 updated by: Ana Ellen de Queiroz Santiago, Federal University of São Paulo

Assessment of the Effect of Clonidine on Pain, Arterial and Intraocular Pressure and Arrhythmias for Cataract Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Federal University of São Paulo
        • Contact:
        • Principal Investigator:
          • Ana Ellen Santiago, investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cataract surgery
  • topical anesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 2: clonidine 4mcg.kg
this group (group 2) will receive 4mcg.kg-1 of clonidine 20 minutes before surgery.
Drug: Clonidine
4 mcg.kg-1, 20 minutes before cataract surgery
Other Names:
  • cataract surgery
  • anesthesic drugs
Placebo Comparator: Group 1: sterile saline solution
this group (Group 1) will receive a sample injection of sterile saline solution 20 minutes before surgery
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of pain
Time Frame: 30 minutes before surgery, during the surgery
Pain intensity will be assessed by numeric rating scale.
30 minutes before surgery, during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure
Time Frame: 30 minutes and during the surgery
Intra-ocular pressure will be assessed with a manual tonometer of perkins.
30 minutes and during the surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
antiarrythmic effect
Time Frame: 30 minutes before surgery and during the surgery
The antiarrythmic effect will be assessed with the continuous measure by Holter.
30 minutes before surgery and during the surgery
blood pressure
Time Frame: 30 minutes before and during the surgery
Blood pressure will be monitorized with a multiparameter monitor, a non-invasive measure.
30 minutes before and during the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Rioko K Sakata, Study Chair, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 0609/01-clonidine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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