A Phase 4 interventional study of CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM and MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY in Anxiety, sponsored by University of Oklahoma. Terminated at 1 site in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by University of Oklahoma · Phase 4, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 115 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One hour Alpha-Stim intervention with sham midazolam
Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM
Sham Alpha-Stim intervention with real midazolam administration
Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY
No Alpha-Stim and only topical anesthetics
Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
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
Also known as: AlphaStim
CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
Also known as: VERSED
NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
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
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
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
Heart Rate During Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
| Milestone | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo |
|---|---|---|---|
| Started | 39 | 38 | 38 |
| Completed | 39 | 38 | 38 |
| Not completed | 0 | 0 | 0 |
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
| units on a scale | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo |
|---|---|---|---|
| Anxiety During Cataract Surgery Under Topical Anesthesia | 3.19 (1 to 8) | 2.96 (1 to 9) | 4.10 (1 to 10) |
VAS from 0 to 10 with 10 being maximal discomfort percieved
| units on a scale | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo |
|---|---|---|---|
| Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia | 2.58 (1 to 7) | 2.66 (1 to 8) | 2.79 (1 to 8) |
| mmHg | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo |
|---|---|---|---|
| Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia | 99.5 (74.6 to 135.3) | 99.8 (66.7 to 126.3) | 104.5 (79 to 124.5) |
| Beats per minute | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo |
|---|---|---|---|
| Heart Rate During Cataract Surgery Under Topical Anesthesia | 64.6 (53 to 88) | 65.4 (48 to 80) | 67.9 (47 to 98) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alpha-Stim Intervention | — | 0/39 (0%) | 0/39 (0%) |
| Sham Alpha-Stim With Midazolam | — | 0/38 (0%) | 0/38 (0%) |
| Placebo | — | 0/38 (0%) | 0/38 (0%) |
| Age, Customized(Participants) | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo | Total |
|---|---|---|---|---|
| 50-90 years | 39 | 38 | 38 | 115 |
| Sex: Female, Male(Participants) | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 39 | 38 | 38 | 115 |
| Region of Enrollment(Participants) | Alpha-Stim Intervention | Sham Alpha-Stim With Midazolam | Placebo | Total |
|---|---|---|---|---|
| United States | 39 | 38 | 38 | 115 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of Oklahoma