Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Phase 4TerminatedNCT00928772

University of Oklahoma115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

115

Conditions

Anxiety

Interventions

CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAMDEVICE

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

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPYDRUG

CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSEDOTHER

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.