Status:
TERMINATED
Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety
Lead Sponsor:
University of Oklahoma
Conditions:
Anxiety
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
Detailed Description
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00928772
Start Date
July 1 2009
End Date
February 1 2012
Last Update
April 20 2017
Active Locations (1)
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1
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104