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Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety - NCT00928772-73104(Clinical Trial 440851)



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City:  Oklahoma City
State:  
OK
Zip Code: 73104
Conditions: Anxiety
Purpose: Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
Study summary: CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.
Criteria: Inclusion Criteria: - Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia. - ASA classification I II and III Exclusion Criteria: - ASA classification IV (patients with a chronic or severe disease). - Hypersensitivity to midazolam or benzodiazepines - acute narrow-angle glaucoma - untreated open-angle glaucoma - Patients with any sort of psychiatric or neurological disorder - Patients on anti-anxiety medication - Patients who have demand-type pacemakers installed before 1999* *Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
Study is available at: Oklahoma City VA Medical Center
Oklahoma City, OK 73104
United States

Primary Contact:
Grigory Chernyak, MD
Phone: 405-326-1885

Secondary Contact:
Grigory Chernyak, MD
Email: gvchus@yahoo.com
Phone: 405-326-1885
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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