Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

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

Detailed Description
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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.

Official Title
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The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery

Conditions
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Anxiety

Intervention / Treatment
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* Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM
* Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY
* Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-Stim intervention<br>One hour Alpha-Stim intervention with sham midazolam | Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM<br>* APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION<br>* Other names: AlphaStim;|
| Sham Comparator: Sham Alpha-Stim with midazolam<br>Sham Alpha-Stim intervention with real midazolam administration | Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY<br>* CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION<br>* Other names: VERSED;|
| Placebo Comparator: Placebo<br>No Alpha-Stim and only topical anesthetics | Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED<br>* NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety During Cataract Surgery Under Topical Anesthesia | Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious. | during the cataract surgery up to30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | VAS from 0 to 10 with 10 being maximal discomfort percieved | during cataract surgery up to 30 minutes | 
| Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia |  | during cataract surgery up to 30 minutes | 
| Heart Rate During Cataract Surgery Under Topical Anesthesia |  | during cataract surgery up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation