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Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

NCT00928772 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2017-04-20

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Grigory Chernyak · Oklahoma City VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928772 on ClinicalTrials.gov