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Lack of efficacy
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Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-Stim intervention | Active Comparator | One hour Alpha-Stim intervention with sham midazolam |
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| Sham Alpha-Stim with midazolam | Sham Comparator | Sham Alpha-Stim intervention with real midazolam administration |
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| Placebo | Placebo Comparator | No Alpha-Stim and only topical anesthetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grigory Chernyak | Oklahoma City VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma City VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alpha-Stim Intervention | One hour Alpha-Stim intervention with sham midazolam CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY | Drug | CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION |
|
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| NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED | Other | NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM. |
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| during cataract surgery up to 30 minutes |
| Heart Rate During Cataract Surgery Under Topical Anesthesia | during cataract surgery up to 30 minutes |
| FG001 |
| Sham Alpha-Stim With Midazolam |
Sham Alpha-Stim intervention with real midazolam administration MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION |
| FG002 | Placebo | No Alpha-Stim and only topical anesthetics NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alpha-Stim Intervention | One hour Alpha-Stim intervention with sham midazolam CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: 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 |
| BG001 | Sham Alpha-Stim With Midazolam | Sham Alpha-Stim intervention with real midazolam administration MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION |
| BG002 | Placebo | No Alpha-Stim and only topical anesthetics NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anxiety During Cataract Surgery Under Topical Anesthesia | Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious. | Posted | Mean | Full Range | units on a scale | during the cataract surgery up to30 minutes |
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| Secondary | Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | VAS from 0 to 10 with 10 being maximal discomfort percieved | Posted | Mean | Full Range | units on a scale | during cataract surgery up to 30 minutes |
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| Secondary | Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia | Posted | Mean | Full Range | mmHg | during cataract surgery up to 30 minutes |
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| Secondary | Heart Rate During Cataract Surgery Under Topical Anesthesia | Posted | Mean | Full Range | Beats per minute | during cataract surgery up to 30 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alpha-Stim Intervention | One hour Alpha-Stim intervention with sham midazolam CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: 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 | 0 | 39 | 0 | 39 | ||
| EG001 | Sham Alpha-Stim With Midazolam | Sham Alpha-Stim intervention with real midazolam administration MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION | 0 | 38 | 0 | 38 | ||
| EG002 | Placebo | No Alpha-Stim and only topical anesthetics NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM. | 0 | 38 | 0 | 38 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grigory Chernyak, MD | VAMC | 405-326-1885 | grigory.chernyak@va.gov |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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