Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

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

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

Study Overview

• Status: Terminated
• Conditions: Anxiety
• Intervention / Treatment: Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM; Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY; Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma City VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alpha-Stim intervention; One hour Alpha-Stim intervention with sham midazolam	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; Other Names: AlphaStim
Sham Comparator: Sham Alpha-Stim with midazolam; Sham Alpha-Stim intervention with real midazolam administration	Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY; CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION; Other Names: VERSED
Placebo Comparator: Placebo; No Alpha-Stim and only topical anesthetics	Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED; NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia		during cataract surgery up to 30 minutes
Heart Rate During Cataract Surgery Under Topical Anesthesia		during cataract surgery up to 30 minutes

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Grigory Chernyak, Oklahoma City VAMC

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Cranial Electro Stimulation; First Eye Cataract Surgery; Preoperative sedation; Perioperative sedation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 14694