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Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Primary Purpose

Anxiety

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oklahoma City VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

Alpha-Stim intervention

Sham Alpha-Stim with midazolam

Placebo

Arm Description

One hour Alpha-Stim intervention with sham midazolam

Sham Alpha-Stim intervention with real midazolam administration

No Alpha-Stim and only topical anesthetics

Outcomes

Primary Outcome Measures

Anxiety During Cataract Surgery Under Topical Anesthesia

Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.

Secondary Outcome Measures

Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia

VAS from 0 to 10 with 10 being maximal discomfort percieved

Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia

Heart Rate During Cataract Surgery Under Topical Anesthesia

Full Information

NCT ID

NCT00928772

First Posted

June 25, 2009

Last Updated

April 19, 2017

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT00928772

Brief Title

Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Official Title

The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy

Study Start Date

July 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alpha-Stim intervention

Arm Type

Active Comparator

Arm Description

One hour Alpha-Stim intervention with sham midazolam

Arm Title

Sham Alpha-Stim with midazolam

Arm Type

Sham Comparator

Arm Description

Sham Alpha-Stim intervention with real midazolam administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

No Alpha-Stim and only topical anesthetics

Intervention Type

Device

Intervention Name(s)

CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM

Other Intervention Name(s)

AlphaStim

Intervention Description

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

Drug

Intervention Name(s)

MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

Other Intervention Name(s)

VERSED

Intervention Description

CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

Intervention Type

Other

Intervention Name(s)

NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

Intervention Description

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

Primary Outcome Measure Information:

Title

Anxiety During Cataract Surgery Under Topical Anesthesia

Description

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 Outcome Measure Information:

Title

Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia

Description

VAS from 0 to 10 with 10 being maximal discomfort percieved

Time Frame

during cataract surgery up to 30 minutes

Title

Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia

Time Frame

during cataract surgery up to 30 minutes

Title

Heart Rate During Cataract Surgery Under Topical Anesthesia

Time Frame

during cataract surgery up to 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grigory Chernyak

Organizational Affiliation

Oklahoma City VAMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oklahoma City VA Medical Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

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Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

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