Anxiety
Conditions
Keywords
Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation
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 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.
Interventions
DEVICECRANIAL 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
DRUGMIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY
CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
OTHERNO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety During Cataract Surgery Under Topical Anesthesia | during the cataract surgery up to30 minutes | Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | during cataract surgery up to 30 minutes | VAS from 0 to 10 with 10 being maximal discomfort percieved |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 39 |
| Sham Alpha-Stim With Midazolam Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION | 38 |
| 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. | 38 |
| Total | 115 |
Baseline characteristics
| Characteristic | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo | Total |
|---|---|---|---|---|
| Age, Customized 50-90 years | 39 Participants | 38 Participants | 38 Participants | 115 Participants |
| Region of Enrollment United States | 39 Participants | 38 Participants | 38 Participants | 115 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 39 Participants | 38 Participants | 38 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 | 0 / 38 |
Outcome results
Primary
Anxiety During Cataract Surgery Under Topical Anesthesia
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
Time frame: during the cataract surgery up to30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alpha-Stim Intervention | Anxiety During Cataract Surgery Under Topical Anesthesia | 3.19 units on a scale |
| Sham Alpha-Stim With Midazolam | Anxiety During Cataract Surgery Under Topical Anesthesia | 2.96 units on a scale |
| Placebo | Anxiety During Cataract Surgery Under Topical Anesthesia | 4.10 units on a scale |
Secondary
Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia
VAS from 0 to 10 with 10 being maximal discomfort percieved
Time frame: during cataract surgery up to 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alpha-Stim Intervention | Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | 2.58 units on a scale |
| Sham Alpha-Stim With Midazolam | Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | 2.66 units on a scale |
| Placebo | Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | 2.79 units on a scale |
Secondary
Heart Rate During Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alpha-Stim Intervention | Heart Rate During Cataract Surgery Under Topical Anesthesia | 64.6 Beats per minute |
| Sham Alpha-Stim With Midazolam | Heart Rate During Cataract Surgery Under Topical Anesthesia | 65.4 Beats per minute |
| Placebo | Heart Rate During Cataract Surgery Under Topical Anesthesia | 67.9 Beats per minute |
Secondary
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alpha-Stim Intervention | Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia | 99.5 mmHg |
| Sham Alpha-Stim With Midazolam | Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia | 99.8 mmHg |
| Placebo | Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia | 104.5 mmHg |