Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00928772
First received: June 25, 2009
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Anxiety
Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM
Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY
Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Patients sedated with Cranial Electro Stimulation vs traditional sedation with midazolam will have adequate perioperative sedation without side effects related to use of benzodiazepines. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgeons performing cataract surgery on the patients sedated with Cranial Electro Stimulation rather than midazolam will be more satisfied due to sufficient sedation but less patient's drowsiness and more alertness during the surgery. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00928772

Locations
United States, Oklahoma
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Grigory Chernyak Oklahoma City VAMC
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00928772     History of Changes
Other Study ID Numbers: 14694
Study First Received: June 25, 2009
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Oklahoma:
Cranial Electro Stimulation
First Eye Cataract Surgery
Preoperative sedation
Perioperative sedation

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014