NCT00928772

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_4 anxiety

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4 anxiety

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

June 25, 2009

Results QC Date

April 19, 2017

Last Update Submit

April 19, 2017

Conditions

Anxiety

Keywords

Cranial Electro StimulationFirst Eye Cataract SurgeryPreoperative sedationPerioperative sedation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia

    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

Study Arms (3)

Alpha-Stim intervention

ACTIVE COMPARATOR

One hour Alpha-Stim intervention with sham midazolam

Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM

Sham Alpha-Stim with midazolam

SHAM COMPARATOR

Sham Alpha-Stim intervention with real midazolam administration

Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

Placebo

PLACEBO COMPARATOR

No Alpha-Stim and only topical anesthetics

Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED

Interventions

CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAMDEVICE

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

Also known as: AlphaStim
Alpha-Stim intervention
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPYDRUG

CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION

Also known as: VERSED
Sham Alpha-Stim with midazolam
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSEDOTHER

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

Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Grigory Chernyak, MD
Organization
VAMC
grigory.chernyak@va.gov
405-326-1885

Study Officials

  • Grigory Chernyak

    Oklahoma City VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 20, 2017

Results First Posted

April 20, 2017

Record last verified: 2017-04

Locations

US(1)