Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Midazolam

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.