Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

University of Oklahoma (OU)

Status and phase: Terminated; Phase 4

Conditions: Anxiety

Treatments: Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM; Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY; Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

Study type: Interventional

Funder types: Other

Identifiers

NCT00928772

14694

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 115 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

115 participants in 3 patient groups, including a placebo group

Alpha-Stim intervention

Active Comparator group

Description:

One hour Alpha-Stim intervention with sham midazolam

Treatment:

Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM

Sham Alpha-Stim with midazolam

Sham Comparator group

Description:

Sham Alpha-Stim intervention with real midazolam administration

Treatment:

Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

Placebo

Placebo Comparator group

Description:

No Alpha-Stim and only topical anesthetics

Treatment:

Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED