Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00928772
• Other study ID #: 14694
• Status: Terminated
• Phase: Phase 4
• First received: June 25, 2009
• Last updated: April 19, 2017
• Start date: July 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• 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

Drug:
• MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY
CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

Other:
• NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Locations

Country	Name	City	State
United States	Oklahoma City VA Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety During Cataract Surgery Under Topical Anesthesia	Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.	during the cataract surgery up to30 minutes
Secondary	Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia	VAS from 0 to 10 with 10 being maximal discomfort percieved	during cataract surgery up to 30 minutes
Secondary	Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia		during cataract surgery up to 30 minutes
Secondary	Heart Rate During Cataract Surgery Under Topical Anesthesia		during cataract surgery up to 30 minutes