Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedation Methods During Cataract Surgery

NCT03054103

Phacoemulsification Cataract

COMPLETED PHASE4

Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

NCT05692167

Dexmedetomidine Cataract Surgery Peribulbar +1 more

UNKNOWN PHASE2

The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia

NCT04018703

Balanced Anesthesia Adjuvants,Anesthesia

UNKNOWN NA

Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

NCT03735368

Conscious Sedation

COMPLETED PHASE2

An Extension Test of Whether to Use Oral Anti-anxiety Drugs (XANAX) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction

NCT06874452

Ophthalmology Cataract Surgery Anesthesia Oral Anxiolytic +1 more

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alpha-Stim intervention

One hour Alpha-Stim intervention with sham midazolam

Group Type ACTIVE_COMPARATOR

CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM

Intervention Type 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

Sham Alpha-Stim with midazolam

Sham Alpha-Stim intervention with real midazolam administration

Group Type SHAM_COMPARATOR

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

Intervention Type DRUG

CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

Placebo

No Alpha-Stim and only topical anesthetics

Group Type PLACEBO_COMPARATOR

NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

Intervention Type OTHER

NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

Intervention Type DRUG

NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AlphaStim VERSED

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No