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Assessment of the Effect of Clonidine for Cataract Surgery

NCT ID: NCT01677351

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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®.

Conditions

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Pain Arrythmia

Keywords

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clonidine cataract surgery arrythmia anesthesic medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group 2: clonidine 4mcg.kg

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

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

4 mcg.kg-1, 20 minutes before cataract surgery

Group 1: sterile saline solution

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Clonidine

4 mcg.kg-1, 20 minutes before cataract surgery

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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cataract surgery anesthesic drugs

Eligibility Criteria

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Inclusion Criteria

* cataract surgery
* topical anesthesia

Exclusion Criteria

* myocardial ischemia
* psychiatric disease
* chronic pain
* drugs dependency
* use of beta-blockage channel drugs
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ana Ellen de Queiroz Santiago

medical resident, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rioko K Sakata, Study Chair

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Ana Ellen Santiago, investigator

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25276415 (View on PubMed)

Other Identifiers

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CEP 0609/01-clonidine

Identifier Type: -

Identifier Source: org_study_id